[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangxi University of Traditional Chinese Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,72,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100634153","phase-1-a-randomized-controlled-trial-of-combined-bu-shen-yi-qi-decoction-and-dehydroepiandrosterone-dhea-for-the-treatment-of-ovarian-function-decline-100634153",false,"NCT07535983","A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline","A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Bu Shen Yi Qi Formula With Chinese Herbal Placebo Combined With Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Dysfunction","Inclusion Criteria:\n\n1. Patients who meet both the Western medical diagnostic criteria for DOR and the Traditional Chinese Medicine (TCM) diagnostic criteria.\n2. Female patients aged 20-40 years (inclusive).\n3. No use of estrogen or progestin medications within the past three months.\n4. Voluntary participation in this study, with informed consent provided and a written informed consent form signed.\n\nExclusion Criteria:\n\n1. Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment efficacy, including:Polycystic ovary syndrome(PCOS),Hyperprolactinemia (a single elevated prolactin level \\> 3 times the upper limit of normal),Poorly controlled thyroid disease (thyroid-stimulating hormone \\[TSH\\] outside the normal reference range),Addison's disease,Systemic lupus erythematosus (SLE),Crohn's disease,Poorly controlled diabetes mellitus, etc.\n2. Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy\u002FChemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles\n3. Any of the following untreated or severe gynecological conditions:Unexplained irregular vaginal bleeding、Adnexal mass with a single largest diameter ≥ 4 cm、Stage III-IV endometriosis or bilateral ovarian endometriomas、Uterine fibroid(s) with a single largest diameter ≥ 4 cm、Endometrial polyp(s) with a single largest diameter \\> 1.5 cm、Planned pelvic surgery during the trial period\n4. Reduced menstrual flow (oligomenorrhea\u002Fhypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures\n5. Patients with severe diseases of the cardiovascular or cerebrovascular system, liver, kidney, hematopoietic system, or other major organ systems, as well as those with psychiatric disorders or intellectual disabilities.\n6. Pregnancy or lactation.\n7. Known allergy or hypersensitivity to any component of the investigational drugs in this study.\n8. Participation in any other clinical trial within the 3 months preceding randomization.\n9. Unwillingness to sign the informed consent form for this study.",true,"FEMALE","20 Years","40 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate the efficacy and safety of Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in the treatment of women with diminished ovarian reserve (DOR). The study also aims to assess the safety profile of this combined therapy.\n\nThe main questions this study aims to answer include:\n\n1. Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR?\n2. Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms?\n3. What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA?\n\nResearchers will compare the Bushen Yiqi formula combined with DHEA to DHEA plus placebo to determine whether the combined therapy is more effective in treating diminished ovarian reserve.\n\nParticipants will:\n\n1. Be randomly assigned to either the treatment group or the control group\n2. Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks\n3. Undergo regular clinical assessments during the study period\n4. Have ovarian reserve markers (including AMH and antral follicle count), sex hormone levels (FSH, LH, E2, and testosterone), traditional Chinese medicine symptom scores, Kupperman menopausal index scores, inflammatory markers (CRP and IL-6), and safety indicators evaluated before and after treatment",[29],"Diminished Ovarian Reserve","RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":34},"2025-09-01",{"date":38,"type":22},"2027-01-01",{"name":40,"class":41},"Jiangxi University of Traditional Chinese Medicine","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"100599022","safety-evaluation-of-pueraria-lobata-radix-in-specific-consumption-scenarios-for-type-2-diabetes-100599022","NCT07079085","Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes","Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes: A Real-World Study","Inclusion Criteria:\n\n1. Diagnosis with T2DM.\n2. Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).\n3. Fulfillment of at least one of the following special scenarios: 1) Excessive dosage: Daily PLR intake ≥ twice the maximum dose specified in the Chinese Pharmacopoeia; 2) Long-term consumption: PLR consumption duration ≥ three months with frequency ≥ three times weekly; 3) Advanced age: ≥ 80 years; 4) Pregnancy; 5) Lactation; 6) Allergic constitution: History of any food or drug allergy; 7) Liver dysfunction: Clinical diagnosis of liver cirrhosis or chronic liver failure, or laboratory findings of total bilirubin \\> 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 2 × ULN; 8) Renal insufficiency: Clinical diagnosis of diabetic nephropathy or chronic nephritis with renal function impairment, or serum creatinine \\> 120% of ULN.\n4. Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.\n\nExclusion Criteria:\n\n1. Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.\n2. Use of PLR compound preparations (e.g., puerarin injection).\n3. Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.","ALL",{"count":52,"type":22},500,"OBSERVATIONAL","This real-world study aims to investigate the association between the consumption of Pueraria lobata radix and adverse events in patients with type 2 diabetes mellitus (T2DM) under special scenarios. By retrospectively analyzing the clinical data of patients with T2DM, we will evaluate the safety profile of Pueraria lobata radix in different special populations, identify potential risk factors, and provide evidence-based support for the safe consumption and clinical use of Pueraria lobata radix.",[56],"Type 2 Diabetes",[58,59,60,61,62],"Pueraria lobata radix","Ge Gen","Type 2 diabetes mellitus","Safety","Real-world study","NOT_YET_RECRUITING","2025-07-18",{"date":66,"type":34},"2025-07-22",{"date":68,"type":22},"2025-08-01",{"date":70,"type":22},"2026-12-30",{"name":40,"class":41},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":50,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100554099","efficacy-and-safety-of-pueraria-lobata-radix-as-an-adjuvant-treatment-for-type-2-diabetes-mellitus-100554099","NCT06494683","Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus","Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes mellitus according to the International Diabetes Guidelines: fasting blood glucose (FBG) ≥ 126 mg\u002Fdl (7.0 mmol\u002Fl) or 2-hour postprandial blood glucose ≥ 200 mg\u002FdL (11.1 mmol\u002Fl), or HbA1c ≥ 6.5% (48 mmol\u002Fmol).\n2. Age between 18 and 80 years old.\n3. Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.\n4. Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.\n5. Willingness to comply with dietary control requirements during the study.\n6. Voluntary participation and signing of informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes, gestational diabetes, and special types of diabetes.\n2. History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.\n3. Pregnant or lactating women, or women planning pregnancy.\n4. Allergy history to Pueraria lobata radix.\n5. Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders.\n6. Anticipated poor compliance or language communication impairments.\n7. Currently participating in other clinical trials.","18 Years","80 Years",{"count":82,"type":22},200,[84],"NA","As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM).",[87],"Type 2 Diabetes Mellitus",[58,59,60,89],"Randomized controlled trial","2025-02-19",{"date":92,"type":34},"2025-02-21",{"date":94,"type":34},"2024-07-25",{"date":96,"type":22},"2025-12-30",{"name":40,"class":41},2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":50,"minAge":79,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":42},"100563066","efficacy-and-safety-of-electroacupuncture-on-lumbar-disc-herniation-with-radiculopathy-100563066","NCT06611332","Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy","Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged from 18 to 70 years old.\n2. With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.\n3. With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;\n4. Voluntarily participating the trial and signing the informed consent form.\n\nExclusion Criteria:\n\n1. Previous surgical treatment of the spine.\n2. Received any physical therapy for lumbar disc herniation within the recent 3 months.\n3. Complicated with diseases that can cause low back and leg pain.\n4. Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.\n5. Previous severe mental illness, organ failure, or malignant tumor.\n6. Planned spinal surgery or other major surgeries within the next 3 months.\n7. Pregnancy or lactation.","70 Years",{"count":108,"type":22},170,[84],"Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.",[112,113],"Lumbar Disc Herniation","Radiculopathy Lumbar",[115,116,117,118,119],"electroacupuncture","radiculopathy","sham control","randomized controlled trial","lumbar disc herniation","2024-09-23",{"date":122,"type":34},"2024-09-24",{"date":124,"type":22},"2024-10-15",{"date":126,"type":22},"2025-10-25",{"name":40,"class":41},""]