[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"All India Institute of Medical Sciences, Bhubaneswar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":410},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,69,95,119,146,185,211,238,263,284,308,339,363,390],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642282","magnesium-bisglycinate-in-major-depressive-disorder-100642282",false,"NCT07633080","Magnesium Bisglycinate in Major Depressive Disorder","Efficacy and Safety of Add-on Magnesium Bisglycinate in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial","DReAM-BiG","Inclusion Criteria:\n\n1. Patients with a diagnosis of Major Depressive Disorder (MDD) as per DSM-5 criteria.\n2. Patients of either sex within the age group of 18-65 years.\n3. Mild to severe depression, defined as a baseline MADRS score ≥7.\n4. Currently receiving a stable dose of antidepressant monotherapy (SSRI or SNRI) in equivalent doses.\n5. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or allergy to magnesium supplements or glycine.\n2. History of renal impairment (previous history of AKI, CKD, currently on dialysis).\n3. Diagnosis of bipolar affective disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.\n4. Active suicidal ideation with intent or a recent suicide attempt (within the past 6 months), as assessed by the treating psychiatrist.\n5. Current substance use disorder (except nicotine, alcohol and caffeine), as per DSM-5 criteria.\n6. Pregnancy, lactation, or women of childbearing potential not using adequate contraception.\n7. Concurrent use of magnesium-containing supplements, antacids, or laxatives.\n8. History of significant severe medical comorbidity, including uncontrolled hypothyroidism, Cushing's syndrome, active malignancy, myasthenia gravis, or severe hepatic impairment.\n9. Use of medications with significant pharmacokinetic interactions with magnesium (e.g., tetracyclines, fluoroquinolones, bisphosphonates, diuretics) that cannot be temporally separated by ≥2 hours.\n10. Electroconvulsive therapy (ECT) received within the past 3 months.","ALL","18 Years","65 Years",{"count":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25],"NA","Depression is a common illness that can affect a person's mood, sleep, energy, ability to work, and overall quality of life. While medicines are available to treat depression, many people do not get complete relief from their symptoms. This study will evaluate whether adding a magnesium supplement in the form of magnesium bisglycinate to regular antidepressant treatment can help improve symptoms of depression. Adults with depression who are already receiving treatment will be randomly assigned to receive either magnesium bisglycinate or a placebo (an inactive substance) along with their usual medication. The study will compare the two groups to see whether the supplement leads to greater improvement in symptoms, sleep, and day-to-day functioning. Information on any side effects will also be collected. The findings may help determine whether magnesium bisglycinate can be used as a safe and affordable additional treatment for people with depression.",[28],"Major Depressive Disorder","RECRUITING","2026-06-12",{"date":32,"type":33},"2026-06-15","ACTUAL",{"date":30,"type":33},{"date":36,"type":22},"2028-06-12",{"name":38,"class":39},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100631712","phase-4-hyaluronic-acid-vs-mitomycin-c-in-external-dacryocystorhinostomy-100631712","NCT07504250","Hyaluronic Acid vs Mitomycin-C in External Dacryocystorhinostomy","Efficacy of Hyaluronic Acid as Intraoperative Adjuvant in External Dacryocystorhinostomy Compared to Mitomycin-C: A Randomized Controlled Trial","HAM-DCR","Inclusion Criteria:\n\n1. All patients within age group 18-65 years diagnosed with chronic dacryocystitis due to Primary Acquired Nasolacrimal Duct Obstruction (PANDO) qualifying for external dacryocystorhinostomy\n2. Patients with resolved acute dacryocystitis\n\nExclusion Criteria:\n\n1. Acute dacryocystitis\u002F Lacrimal sac abscess\n2. Secondary NLDO conditions such as infections, inflammatory, traumatic, malignant, etc.\n3. Failed\u002F recurrent\u002F revision dacryocystorhinostomy and previous dacryocystectomy\n4. Presence of systemic diseases affecting wound healing (eg: uncontrolled diabetes, autoimmune conditions, etc.)\n5. Use of topical or systemic steroids\u002F immunosuppressants within 1 month prior to surgery\n6. Pregnant or lactating women\n7. Known allergy or hypersensitivity to MMC or HA.\n8. Inadequate tear volume for biomarker analysis or poor sample quality.\n9. Intraoperative flap complications\u002F excessive bleeding\n10. Blood stained discharge or bloody regurgitation\n11. Cervical or generalized lymphadenopathy\n12. Dry eyes",{"count":50,"type":22},36,[52],"PHASE4","RCT to compare the surgical success in patients undergoing external dacryocystorhinostomy with intraoperative Mitomycin-C (0.4 mg\u002Fml) Vs Hyaluronic acid 1% (1ml) as adjuvant, To compare the complication rates and wound healing patterns in each group, To Compare change in tear MMP-9 levels from preoperative (within 1 week before surgery) to postoperative (6 weeks after surgery) , To compare the comfort levels of patients in each group.",[55],"Dacryocystitis",[55,57,58,59],"dacryocystorhinostomy","mitomycin C","hyaluronic acid","NOT_YET_RECRUITING","2026-03-27",{"date":63,"type":33},"2026-03-31",{"date":65,"type":22},"2026-04-01",{"date":67,"type":22},"2027-12-31",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100629763","tumor-margin-skin-tattooing-before-neo-adjuvant-chemotherapy-in-patients-with-breast-cancer-100629763","NCT07478900","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study","TUMS","Inclusion Criteria:\n\nFemale patients aged 18-75 years\n\nHistologically confirmed Breast Cancer on biopsy\n\nPatients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy\n\nPresence of a clinically palpable primary breast tumor suitable for localization\n\nPatients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy\n\nAbility and willingness to provide written informed consent\n\nExclusion Criteria:\n\nKnown allergy or hypersensitivity to tattooing materials used for tumor localization\n\nEarly-stage Breast Cancer not requiring Neoadjuvant Chemotherapy\n\nDiagnosis of Inflammatory Breast Cancer\n\nT3 tumors in patients with small breast size or T4 breast cancer\n\nPatients unwilling to undergo Breast-Conserving Surgery\n\nDiffuse microcalcifications of the breast parenchyma on Mammography\n\nDuctal Carcinoma In Situ\n\nMale Breast Cancer\n\nMulticentric or multifocal breast cancers\n\nTumor location that precludes breast-conserving surgery\n\nRecurrent Breast Cancer","FEMALE","75 Years",{"count":80,"type":22},30,[25],"Study Description\n\nThis prospective cohort study evaluates the feasibility and effectiveness of pre-neoadjuvant tumor localization using skin tattooing, with or without radiopaque clips, in patients with biopsy-proven T2-T3 breast cancer and axillary lymph node metastasis. Eligible patients will undergo tumor localization in the supine position with the ipsilateral arm abducted to 90°. Palpable tumor margins will be marked with sterile tattoo ink, and deep or mobile tumors will receive additional localization with ultrasonography-guided radiopaque clips. Following localization, patients will receive standard neoadjuvant chemotherapy. Tumor response will be monitored clinically and radiologically. Post-therapy, the tattoo markings and\u002For clips will guide breast-conserving surgery. Primary outcomes include feasibility of breast conservation, achievement of negative margins (R0 resection), and avoidance of mastectomy, while intraoperative technical challenges will also be documented.",[84,85,86],"Breast Cancer (Locally Advanced or Metastatic)","Tattoo Skin Markers","Neoadjuvant Chemoimmunotherapy","2026-03-14",{"date":89,"type":33},"2026-03-18",{"date":91,"type":33},"2025-09-10",{"date":93,"type":22},"2028-02-09",{"name":38,"class":39},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":77,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":40},"100627910","phase-1-antibiotics-vs-corticosteroids-in-treatment-of-granulomatous-lobular-mastitis-100627910","NCT07454772","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail","GRANMAS","Inclusion Criteria:\n\n* Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.\n\nExclusion Criteria:\n\n* Declining to participate in the study\n* Pregnant or lactating women\n* Patient already on antibiotic\u002Fsteroid therapy and are responding to treatment\n* Known immunosuppression or diabetes mellitus uncontrolled\n* Patient already on immunosuppression therapy for any other disorder\n* Lost to follow-up before 3 months post-treatment\n* Allergic to one of the antibiotics\u002Fsteroids which will be used\n* Contraindications to oral steroids therapy\n* Contraindications to methotrexate therapy",{"count":104,"type":22},72,[106,107],"PHASE1","PHASE2","The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) - a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth.\n\nThe main questions it aims to answer are:\n\nDoes an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids?\n\nDo steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects?\n\nResearchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates.\n\nParticipants will:\n\nReceive a 14-day antibiotic trial initially (screening phase).\n\nIf no improvement, be randomly assigned to:\n\nGroup A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or\n\nGroup B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks.\n\nUndergo evaluation after 2 months:\n\nIf not fully recovered, receive Methotrexate + Folic acid for another 8 weeks.\n\nIf still no improvement, switch to the alternate treatment or undergo surgery if required.\n\nAttend regular follow-ups for 6 months for clinical assessment and monitoring of side effects.\n\nThis 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women.",[110],"Granulomatous Mastitis","2026-03-04",{"date":113,"type":33},"2026-03-06",{"date":115,"type":22},"2026-03-15",{"date":117,"type":22},"2027-07-04",{"name":38,"class":39},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":40},"100627206","comparison-of-accelerated-intermittent-theta-burst-stimulation-vs-high-frequency-transcranial-magnetic-stimulation-hf-rtms-on-cognitivesymptoms-in-treatment-resistant-schizophrenia-100627206","NCT07445620","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT","DB RCT","Inclusion Criteria:\n\n* Diagnosed with treatment-resistant schizophrenia according to TRIIP Consensus criteria\n* Age: 18-60 years\n* Currently receiving clozapine treatment for at least 6 months\n* Attending psychiatry outpatient department at AIIMS Bhubaneswar\n\nExclusion Criteria:\n\n* Currently receiving or recently received ECT\u002FrTMS\u002FtDCS\n* Co-morbid psychiatric, major medical, or neurological disorders\n* History of withdrawal seizures, delirium tremens, or significant head injury\n* Presence of pacemaker or metal in any part of body (excluding mouth)\n* Pregnant or lactating women","60 Years",{"count":129,"type":22},90,[25],"This randomized, double-blind, sham-controlled trial compares three brain stimulation approaches-accelerated intermittent theta burst stimulation (aITBS), high-frequency repetitive transcranial magnetic stimulation (HF-rTMS), and sham stimulation-for treating cognitive deficits in treatment-resistant schizophrenia. Ninety patients receiving clozapine will be randomized 1:1:1 to receive 20 sessions over 4 weeks targeting the dorsolateral prefrontal cortex. The primary outcome is change in cognitive function measured by B-CATS score at 2, 4, and 12 weeks. Secondary outcomes include social cognition, symptom severity, brain metabolism (FDG-PET), and inflammatory biomarkers.",[133,134],"Psychosis","Schizophrenia Disorder",[136,137],"rTMS","Cognitive deficit","2026-02-27",{"date":140,"type":33},"2026-03-03",{"date":142,"type":22},"2026-02-15",{"date":144,"type":22},"2029-12-14",{"name":38,"class":39},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":167,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":40},"100517290","comorbidities-resolution-after-mgb-surgery-and-change-in-body-composition-100517290","NCT06015620","Comorbidities Resolution After MGB Surgery and Change in Body Composition","CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)","MOGAMBO","Inclusion Criteria:\n\n* All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities\n\nExclusion Criteria:\n\n* Patients not giving consent for the study\n* All patients who were undergoing a redo-procedure for recurrence were excluded from the study",{"count":155,"type":22},35,"OBSERVATIONAL","This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:\n\nTo study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.\n\nOther objectives are:\n\n* Changes in the parameters of the metabolic syndrome after surgery\n* Changes in the cardiovascular risk biomarkers after metabolic surgery\n* Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.\n\nType of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.",[159,160,161,162,163,164,165,166],"Morbid Obesity","Type2diabetes","Sleep Apnea","Hypothyroidism","Hypertension","Lipid Disorder","Non-Alcoholic Fatty Liver Disease","Chronic Venous Hypertension With Ulcer",[168,169,170,171,172,173,174,175,176],"morbid obesity","OSA","mini gastric bypass","metabolic surgery","polysomnography","metabolic syndrome","DEXA scan","bioelectrical impedance","body composition","2026-02-16",{"date":179,"type":33},"2026-02-18",{"date":181,"type":33},"2023-09-01",{"date":183,"type":22},"2027-03-30",{"name":38,"class":39},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":40},"100603076","phase-4-evaluation-of-efficacy-and-safety-of-add-on-tofacitinib-in-patients-with-oral-lichen-planus-100603076","NCT07131813","Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus","Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus.\n* Patients with a PGA score of ≥3 (moderate and severe oral LP).\n* Patients who are willing to give informed written consent.\n\nExclusion Criteria:\n\n* Treatment with a systemic corticosteroid within the last 4 weeks.\n* Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment.\n* Patients with a clinical history and any lesion distribution suspicious of a lichenoid drug eruption, and patients with other skin diseases.\n* Past or current history of any malignancy, including moderate to severe dysplasia of the oral mucosa on oral biopsy.\n* Severe active infection, including active tuberculosis, hepatitis B, or C infection\n* Patients with cytopenia (Hb \\\u003C9g\u002Fdl, leukocyte count \\\u003C4000\u002Fmm3, platelet count \\\u003C100,000\u002Fmm3)\n* The patient with a history of alcohol abuse.\n* Decreased liver or renal function (creatinine \\> 2.0mg\u002Fdl, total bilirubin \\> 2.5 mg\u002Fdl).\n* Severe acute infection, uncontrolled diabetes mellitus, congenital or acquired immunodeficiency, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia, or depression.\n* Patient with a history of hypersensitivity to topical Triamcinolone or Tofacitinib.\n* Pregnancy and lactation, women of childbearing age without effective contraception.",{"count":193,"type":22},60,[52],"Many of the patients with oral lichen planus (OLP) either fail to achieve complete remission or experience frequent relapses with conventional topical corticosteroid therapy, which is currently the mainstay of treatment. Long-term corticosteroid use is limited by local and systemic adverse effects, and many patients develop steroid resistance or intolerance. To overcome these limitations, combination therapy with agents having complementary mechanisms may improve therapeutic outcomes, reduce steroid requirements, and minimize associated adverse effects. Tofacitinib, a Janus kinase (JAK1\u002FJAK3) inhibitor, modulates the JAK-STAT signaling pathway, thereby reducing inflammatory cytokine production involved in OLP pathogenesis. Preliminary case series and pilot trials have shown promising results with tofacitinib in OLP. However, to date, no randomized controlled trial has evaluated the efficacy and safety of add-on oral tofacitinib with standard topical steroid therapy in OLP. Hence, investigators considered tofacitinib to be a candidate drug for add-on therapy due to its anti-inflammatory and immunomodulatory properties. Adding tofacitinib to ongoing topical triamcinolone therapy may increase the response rate, reduce adverse drug reactions by lowering steroid dose requirements, or achieve a quicker therapeutic effect. Therefore, the present randomized controlled trial has been planned to evaluate the efficacy and safety of oral tofacitinib as an add-on therapy in patients with OLP.",[197],"Oral Lichen Planus",[199,197,200,201,202],"Tofacitinib","Randomized Controlled Trial","Placebo","IL 6","2025-11-26",{"date":205,"type":33},"2025-11-28",{"date":207,"type":33},"2025-10-10",{"date":209,"type":22},"2027-06-01",{"name":38,"class":39},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":40},"100577837","phase-4-effect-of-venlafaxine-versus-dosulepin-in-pain-predominant-somatic-symptom-disorder-100577837","NCT06803485","Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder","Effect of Venlafaxine Versus Dosulepin on Clinical Outcomes, Neuroinflammation and Cortisol Level in Pain Predominant Somatic Symptom Disorder: A Group-sequential Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with a primary diagnosis of somatic symptom disorder with pain predominance (DSM-5).\n* Patients of either sex within the age group of 18-65 years.\n* Patients with PHQ-15 score of ≥ 5.\n* All included patients will be treatment-naïve or have not received any treatment in the last 4 weeks.\n* Patients who have given written informed consent.\n\nExclusion Criteria:\n\n* A diagnosed psychological condition that might require other treatment (e.g., psychosis, suicidality)\n* Patient undergoing current psychotherapy.\n* Patients with cognitive impairment.\n* History of allergy to either of the study drugs (dosulepin or venlafaxine).\n* Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular, neurological or endocrinal, or respiratory dysfunction.\n* Substance abuse history of psychoactive agents.\n* Pregnant and lactating mothers.",{"count":21,"type":22},[52],"Somatic symptom disorder (SSD) is marked by persistent physical complaints, often involving pain, alongside excessive thoughts or behaviors related to health, which substantially disrupt daily functioning. The underlying mechanisms of SSD are multifaceted. The serotonin hypothesis links low serotonin levels to the development of somatic symptoms, while the cortisol hypothesis highlights dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, with chronic stress often associated with hypocortisolism. Furthermore, the neuroinflammatory hypothesis suggests that cytokine-driven inflammation and activation of glial cells may intensify pain and somatic symptoms, exacerbating patient outcomes. Challenges such as limited acceptance of the diagnosis, resistance to treatment among patients and caregivers, and societal stigma further hinder effective management.\n\nCurrently, treatment options lack definitive efficacy, with pharmacological interventions primarily targeting serotonin pathways. There is limited exploration of therapies addressing mechanisms like cortisol dysregulation and neuroinflammation. Commonly used medications include tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin reuptake inhibitors (SSRIs), with prescribing decisions often based on physician discretion and patient tolerance rather than clear evidence favoring one class over another.\n\nThe proposed study aims to compare the efficacy and safety of Dosulepin (a TCA) and Venlafaxine (an SNRI) in managing SSD patients with predominant pain. By evaluating their impact on symptom severity, quality of life, and biomarkers such as serum cortisol and TNF-alpha levels, this research seeks to enhance understanding of SSD treatment. The findings aim to address gaps in SSD pharmacotherapy and contribute to improved patient care strategies.",[222],"Somatic Symptom Disorder (DSM-V)",[224,225,226,227,228,229],"Somatic symptom disorder","Dosulepin","Venlafaxine","Somatic syndrome disorder with pain predominance","Cortisol","TNF alpha","2025-09-19",{"date":232,"type":33},"2025-09-24",{"date":234,"type":33},"2025-03-11",{"date":236,"type":22},"2026-11",{"name":38,"class":39},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":244,"sex":245,"minAge":246,"maxAge":127,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100604093","evaluation-of-efficacy-and-safety-of-prosman-prunus-domestica-extract-on-prostate-function-serum-testosterone-levels-and-quality-of-life-100604093","NCT07145034","Evaluation Of Efficacy And Safety Of Prosman™ (Prunus Domestica Extract) On Prostate Function, Serum Testosterone Levels And Quality Of Life","Inclusion Criteria:\n\n* Provide voluntarily signed and dated informed consent.\n* Be in good health as determined by medical history and routine blood chemistries.\n* Age between 40 and 60 yr (inclusive).\n* Body Mass Index of 18.5-34.9 (inclusive).\n* Body weight of at least 55 kg.\n* An IPSS score of 8-19 (inclusive).\n* Symptoms of benign prostatic hyperplasia (BPH) for at least 6 months prior to screening (e.g. Incomplete emptying: the feeling the bladder is full, even after passing urine; Frequency: the need to pass urine often, about every one to two hours; Intermittency: the need to stop and start several times when passing urine; Urgency: feeling the urgent need to pass urine; Weak stream: a weak urine flow; Straining: trouble starting to pass urine or the need to push or strain to pass urine; Nocturia: the need to wake up at night more than two times to pass urine.\n* Normotensive (seated, resting systolic blood pressure \\\u003C140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.\n* The subject is willing and able to comply with the study protocol.\n\nExclusion Criteria:\n\n* Current neurogenic bladder dysfunction.\n* Current bladder neck contracture or urethral stricture.\n* Current acute or chronic prostatitis or UTI.\n* History of prostate cancer.\n* Use of any other herbal medication for the treatment of BPH, associated symptoms, and erectile dysfunction within the past month.\n* Current hematuria of unknown etiology.\n* History of radiotherapy.\n* History of unstable or new-onset cardiovascular\u002Fcardiorespiratory, liver, or renal conditions.\n* History of diabetes or endocrine disorder.\n* History of use of medications or dietary supplements known to confound the study or its endpoints.\n* Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.\n* Current smokers or smoking within the past month.\n* History of hyperparathyroidism or an untreated thyroid condition.\n* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).\n* Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS\u002FIBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).\n* Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV\u002FAIDS, etc.).\n* Known sensitivity to any ingredient in the test formulations as listed in the product label.\n* Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.\n* Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.",true,"MALE","40 Years",{"count":248,"type":22},38,[25],"This study is designed to test the safety and effectiveness of a plant-based supplement called Prosman™ (made from Prunus domestica extract) for men with symptoms of benign prostate hyperplasia (BPH), a common non-cancerous enlargement of the prostate gland that causes urinary problems in older men.\n\nKey Points:\n\nPurpose: The main goal is to see if Prosman™ can improve prostate health, hormone levels, and quality of life in men aged 40 to 60 who have BPH symptoms.\n\nHow the Study Works:\n\n38 men will be randomly assigned to take either Prosman™ or a placebo (a dummy pill) every day for 8 weeks.\n\nThe study is randomized and controlled, meaning neither the participants nor the researchers know who is getting Prosman™ or the placebo.\n\nMeasurements:\n\nProstate health will be measured using a symptom score.\n\nBlood tests will check hormone levels and other health markers.\n\nQuality of life will also be tracked.\n\nSafety: The study will monitor for any side effects or health problems during the trial.\n\nWhy It Matters: Current medications for BPH can have unwanted side effects, so there is interest in plant-based alternatives like Prosman™, which may offer benefits with fewer risks.\n\nThe study follows strict ethical guidelines to protect participants' privacy and safety. Data will be kept confidential, and participants can leave the study at any time.",[252],"Healthy",[254],"BPH","2025-08-29",{"date":257,"type":33},"2025-09-05",{"date":259,"type":22},"2025-09-07",{"date":261,"type":22},"2026-09-30",{"name":38,"class":39},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":244,"sex":245,"minAge":270,"maxAge":246,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":40},"100603973","effect-of-rhizomk-on-testosterone-levels-the-anabolic-response-to-exercise-and-overall-quality-of-life-in-physically-active-healthy-males-100603973","NCT07143474","Effect of RhizomK on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males","A Randomized Double-blind Placebo Controlled Clinical Study to Evaluate the Impacts of RhizomK as Compared to Placebo on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males","Inclusion Criteria:\n\n* Male sex, aged 21 to 40 (inclusive)\n* Currently engaged in, and has been engaged in resistance training\n* (i.e., weightlifting), training three or more times per week for at least\n* the prior 12 months.\n* Healthy subject (no medical conditions that per the PI assessment).\n* No significant past medical history\n* No significant past surgical history that in the opinion of the PI\n* would preclude study participation.\n* Passes the screening with Physical Activity Readiness questionnaire (PAR-Q)\n* Not currently or recently (within the prior eight-weeks) taken a\n* dietary supplement that is purported to increase testosterone\n* levels.\n* Agrees to follow and adhere to the study directions.\n* Agrees that their study visits will be scheduled at a similar time of the day\n* to minimize and potential circadian rhythm impacts.\n\nExclusion Criteria:\n\n* Takes any prescribed medication or over-the-counter medication which is known to affect testosterone levels.\n* Positive medical history of heart disease\u002Fcardiovascular disease, high blood pressure (140\u002F90 or greater mmHg), kidney disease, hepatic impairment or disease, or Type I or Type II diabetes or any other medical condition or diagnosis that the PI would deem exclusionary.\n* Positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV\u002FAIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit.\n* Positive medical history for any gastrointestinal disease or illness Positive history of gastrointestinal surgery that is known to alter or impact the digestion, absorption of nutrients and or fluids (i.e., gastric bypass).\n* History of hospitalization or in-patient or out-patient treatment for alcohol dependence or drug addiction over the past one year.\n* History of hospitalization or in-patient treatment for depression or any mental health related condition within the past one year.\n* Allergic to any of the ingredients in the study product.\n* Subject is unwilling to follow study directions.","21 Years",{"count":193,"type":22},[25],"Given that testosterone is a key modulator of muscle protein synthesis and overall anabolic response to resistance training, any natural intervention that boosts testosterone levels could logically contribute to improved exercise performance, lean muscle gain, and subjective vitality. 13 However, despite encouraging preclinical and ethnopharmacological data, clinical validation of Curculigo extract in human participants-especially in the context of exercise and lifestyle enhancement-is lacking. A novel extract of Curculigo orchioides (commercially known as RhizomK™) has been developed. This randomized, double-blind, placebo-controlled study seeks to bridge this crucial gap by evaluating the efficacy and safety of RhizomK™ supplementation in healthy, physically active males. The findings of this study have the potential to substantiate RhizomK™ as a scientifically supported dietary intervention for enhancing hormonal balance, physical performance, and well-being in men who are not candidates for pharmacological therapy but are seeking to optimize their health through lifestyle and supplementation.",[275],"Adult Healthy Volunteers","2025-08-28",{"date":278,"type":33},"2025-09-04",{"date":280,"type":22},"2025-10",{"date":282,"type":22},"2027-02",{"name":38,"class":39},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":40},"100587031","petct-guided-biopsy-versus-ct-guided-biopsy-in-evaluation-of-suspected-lung-neoplasms-100587031","NCT06923098","PET\u002FCT GUIDED BIOPSY VERSUS CT GUIDED BIOPSY IN EVALUATION OF SUSPECTED LUNG NEOPLASMS","Inclusion Criteria:\n\n* Age above 18 years\n* INR \\< 1.2 and platelet counts \\> 80,000\u002Fmm3\n* CT thorax with lung lesion more than 10 mm.\n* Accessible lesions for CT-guided biopsy.\n\nExclusion Criteria:\n\n* Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by -INR ≥1.2 and Platelet counts ≤ 80,000\u002Fmm3\n* Participants who refuse to provide consent\n* Signs of hypoperfusion like hypotension, cyanosis etc.\n* Presence of hypoxemia with SpO2 \\\u003C 94 %- measured in a pulse oximeter)\n* Pregnant\u002FLactating female subjects\n* Non-cooperative subjects\n* Lesions that are inaccessible (decision made on pre-biopsy planning)\n* Serum creatinine level more than 2mg\u002Fdl.",{"count":291,"type":22},108,[25],"Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even regional necrosis, which are hard to be distinguished from tumor on CT images.\n\nFunctional imaging guided biopsy like PET\u002FCT guided biopsy identifies areas of highest concentration of neoplastic cells and provides accurate results. Only a few studies have been done regarding PET\u002FCT guided biopsy and studies omparing PET\u002FCT guided and CT guided percutaneous transthoracic lung biopsy are very few and this study would be a randomized trial comparing these diagnostic modalities in terms of diagnostic yield, diagnostic accuracy of sample and complications.",[295],"Lung Diseases",[297,298,299],"CT guided biopsy","PET-CT guided biopsy","Lung lesions","2025-04-04",{"date":302,"type":33},"2025-04-11",{"date":304,"type":33},"2023-07-01",{"date":306,"type":22},"2025-12",{"name":38,"class":39},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":40},"100547845","ultrasonography-guided-pneumoperitoneum-for-laparoscopic-surgery-in-morbidly-obese-patients-100547845","NCT06413264","Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients","Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL)","USP","Inclusion Criteria:\n\n* All patients in the age group of 18 -65 years undergoing laparoscopic bariatric surgery with weight \\>100 kg\n* Subcutaneous fat thickness of more than 5 cm as determined by pre-operative ultrasonography\n* BMI \\> 40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Patients who don't give consent and do not understand the nature of the study\n* Patients undergoing a re-do surgery",{"count":317,"type":22},40,[25],"Bariatric Surgery for morbid obesity is indicated when BMI \\> 40 kg\u002Fm2 without comorbidities or BMI \\> 35 kg\u002Fm2 with co-morbidities. Different surgeries performed for obesity are classified as restrictive, malabsorptive, and hybrid procedures.\n\nBecause laparoscopic surgery has increased the interest and growth of bariatric surgery, soaring demand for laparoscopic bariatric surgery from patients has boosted the boom in bariatric surgery worldwide.\n\nAchieving pneumoperitoneum is the initial and one of the most crucial steps in any laparoscopic surgery, giving the surgeon working space to operate on a particular organ\u002Forgan system. Usually, pneumoperitoneum is achieved either by a closed technique with a veress needle or an open technique with many variations like finger assisted or the conventional open technique.\n\nGiven the excess amount of subcutaneous fat in morbidly obese patients, putting a veress needle to achieve pneumoperitoneum successfully is particularly challenging which takes a toll on the operating surgeon when he\u002Fshe is trying to locate the midline one can either overshoot to cause omental emphysema or undershoot getting lost in the subcutaneous fat. It is usually done in the supra umbilical area. Sometimes, due to previous surgical scars other sites are preferred.\n\nSonography is routinely used by radiologists with negligible radiation exposure. Anesthesiologists in the operating room have used it for many assisted procedures like central line insertion \u002F giving nerve blocks. It can also be used in obese patients undergoing metabolic surgery to assist in creating pneumoperitoneum by a veress needle.\n\nAdvantages of Intraoperative ultrasonography in this particular study :\n\n1. To quantify the thickness of subcutaneous fat\n2. To visualise the linea alba and guide the veress needle safely into the peritoneal cavity\n3. Real-time visualisation of the pneumoperitoneum created\n4. Avoid complications like omental emphysema, bowel or vascular injury",[321,159,322],"Pneumoperitoneum","Bariatric Surgery Candidate",[324,325,326,327,328,329,171,330],"pneumoperitoneum","closed technique","Veress needle","ultrasonography-guided","morbidly obese","bariatric surgery","access-related injury","2024-07-29",{"date":333,"type":33},"2024-07-30",{"date":335,"type":33},"2024-07-01",{"date":337,"type":22},"2026-06-30",{"name":38,"class":39},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":4},"100554611","phase-4-maintenance-electroconvulsive-therapy-ect-versus-aripiprazole-in-clozapine-resistant-schizophrenia-100554611","NCT06501339","Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia","Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial","Inclusion Criteria:\n\n1. Patients clinically diagnosed with CRS (currently under clozapine)\n2. Patients aged 18-60 years of either sex.\n3. LAR giving voluntary written consent for participation in the study\n\nExclusion Criteria:\n\n1. Patient already on ECT or aripiprazole.\n2. History of psychoactive substance abuse or dependence.\n3. Co-morbid psychiatric, major medical or neurological disorders.\n4. History of organicity or significant head injury.\n5. Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.",{"count":317,"type":22},[52],"The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.",[350],"Clozapine Resistant Schizophrenia",[352,353,354,355],"Clozapine resistant","schizophrenia","Aripiprazole","m-ECT","2024-07-15",{"date":358,"type":33},"2024-07-16",{"date":360,"type":22},"2024-08-10",{"date":63,"type":22},{"name":38,"class":39},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":244,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":378,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":40},"100554944","effect-of-atenolol-versus-ivabradine-on-hrv-in-trs-patients-on-clozapine-with-tachycardia-a-randomised-control-trial-100554944","NCT06505668","Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.","Effect Of Atenolol Versus Ivabradine On Heart Rate Variability In Treatment Resistant Schizophrenia Patients On Clozapine With Tachycardia: A Randomized Control Trial.","Inclusion Criteria:\n\nAll patients coming for treatment at the Out-patient department and In-patient department of the Department of Psychiatry fulfilling the following are included:\n\n1. Patients diagnosed with TRS (TRRIP consensus) receiving clozapine.\n2. Aged between 18 to 60 years of either sex\n3. Having baseline heart rate of \\>100\u002Fminute.\n4. Written informed consent from Legally Authorized representative.\n\nExclusion Criteria:\n\nPatients with any one of the following are excluded from the study:\n\n1. Already receiving Atenolol or Ivabradine.\n2. Patients having any contraindication to using Atenolol or Ivabradine.\n3. Receiving any other medication other than Clozapine known to cause autonomic dysregulation.\n4. Active substance use.\n5. Serious medical or neurological comorbidity.",{"count":317,"type":22},[25],"Clozapine is the only drug approved for Treatment Resistant Schizophrenia. However, it has been associated with many adverse drug reactions including agranulocytosis, myocarditis, sialorrhea, constipation, orthostasis, tachycardia. There are many factors that have impacted the use of clozapine in TRS patients including physician hesitation, patient denial, stopping of drug due to Adverse drug reactions.\n\nAlthough Tachycardia should not be the reason to stop clozapine, but data shows that it leads to discontinuation of drugs in significant patient population. If patient on clozapine develops tachycardia; first orthostasis, myocarditis and systemic infection should be ruled out. Tachycardia traditionally have been treated with B1 adrenergic blockers such as Atenolol. But the problem with beta blocker medications is that significant proportion develops hypotension.\n\nRecently developed Ivabradine slows heart rate via I(f) current, and is not associated with much cardiac adverse effects. Recent Clinical trials have been carried out to show its effects on Clozapine associated tachycardia which shows promising results. Some studies suggest using Ivabradine in patient population that have contraindication for beta blockers.\n\nAlthough both of these drugs are used widely in clinical practice, but as Ivabradine is relatively new drug there have been no head-to-head comparison with Atenolol. A recent meta-analysis tried to compare treatment efficacy in these patients, but found no studies that met their inclusion criteria. This current study attempts to make such comparison and guide further research.",[374,375,376,377],"Treatment Resistant Schizophrenia","Clozapine Adverse Reaction","Heart Rate Variability","Tachycardia",[379,380,381],"Clozapine","Treatment resistant schizophrenia","heart rate variability","2024-07-11",{"date":384,"type":33},"2024-07-17",{"date":386,"type":33},"2023-08-01",{"date":388,"type":22},"2025-06-30",{"name":38,"class":39},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":40},"100554056","efficacy-and-safety-of-tacs-vs-tdcs-in-schizophrenia-100554056","NCT06494124","Efficacy and Safety of tACS vs tDCS in Schizophrenia","Comparison of Efficacy and Safety of Transcranial Alternating Current Stimulation vs Transcranial Direct Current Stimulation on Psychopathology Measures and Neurocognition in Chronic Schizophrenia: A Randomized Double-blind Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years\n2. Moderate-severe symptoms (PANSS score \\> 75 and\u002For CGI-SCH score\\>4) \\[24\\]\n3. On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)\n4. Both sexes; Age range: 18-60 years\n5. Right-handed\n6. Written informed consent by the patient\n\nExclusion Criteria:\n\n1. Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)\n2. Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp \u002F head\n3. Co-morbid neurological disease\n4. Left Handed",{"count":129,"type":22},[25],"This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.\n\nThe main question it aims to answer is:\n\n• In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?\n\nParticipants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).",[401],"Schizophrenia","2024-07-08",{"date":404,"type":33},"2024-07-10",{"date":406,"type":33},"2024-04-03",{"date":408,"type":22},"2026-06",{"name":38,"class":39},""]