[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SF Research Institute, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":271},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,72,98,118,147,178,207,229,250],{"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":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100626856","effect-of-ashwagandha-root-extract-on-stress-anxiety-and-sleep-quality-in-adults-experiencing-minority-stress-100626856",false,"NCT07441070","Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress","Efficacy and Safety of Ashwagandha (Withania Somnifera) Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress: A Randomized, Double-Blind, Placebo-Controlled Study","Inclusion Criteria:\n\n1. Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary).\n2. Aged 18-45 years.\n3. Moderate to high perceived stress levels (PSS-10 total score \\>14).\n4. Willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Current psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, psychosis).\n2. Use of anti-anxiety or sleep medication (including sleep aids, cannabis or melatonin) in the last 3 months.\n3. Known allergy or intolerance to Ashwagandha.\n4. Any chronic illness that may confound the results (e.g., known liver illness, severe insomnia, or neurological disorders).",true,"ALL","18 Years","45 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Sexual and gender minority adults often experience elevated levels of chronic stress due to stigma, discrimination, and social adversity, commonly referred to as minority stress. This persistent stress is associated with increased anxiety, mood disturbances, impaired sleep quality, and reduced quality of life. There is a need for safe, non-pharmacological interventions that can support mental well-being in this population.\n\nThis randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root extract in reducing stress and improving anxiety and sleep quality in adults experiencing minority stress. A total of 80 adults aged 18 to 45 years who self-identify as sexual or gender minorities and report moderate to high perceived stress will be enrolled.\n\nParticipants will be randomly assigned to receive either Ashwagandha root extract (300 mg capsules taken twice daily) or an identical placebo for 8 weeks. Efficacy will be assessed using validated psychological and quality-of-life questionnaires, including the Perceived Stress Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and other mood and minority stress measures. Salivary cortisol will be measured as a biological marker of stress. Safety will be evaluated through monitoring of adverse events throughout the study.",[28,29,30],"Minority Stress","Psychological Stress","Anxiety",[32,33,34],"Ashwagandha","LGBTQ health","Withania somnifera","RECRUITING","2026-04-22",{"date":38,"type":39},"2026-04-27","ACTUAL",{"date":41,"type":22},"2026-04-29",{"date":43,"type":22},"2026-08-15",{"name":45,"class":46},"SF Research Institute, Inc.","NETWORK",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":71,"locationsCount":47},"100626857","efficacy-and-safety-of-shatavari-root-extract-in-womens-sexual-wellness-100626857","NCT07441083","Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness","Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract in Women's Sexual Wellness: A Prospective, Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study","Inclusion Criteria:\n\n1. Women between 20 to 50 years of age.\n2. Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a FSFI total score ≤ 26.55.\n3. Have a PSS-10 score of ≥ 14 at screening.\n4. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).\n5. Participants who are reliable, honest, compliant, and agree to co operate with all trial evaluations as well as to be able to perform them as per investigator's opinion.\n6. Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.\n7. Able to read and write in English or any other vernacular language.\n8. No plan to commence new treatments over the study period.\n9. Must have the ability and willingness to sign a written informed consent and to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Participants taking any form of herbal extract in the last 3 months before study entry.\n2. Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause\n3. Participants who are on hormone replacement therapy (HRT) for more than 3 months.\n4. Participants with any active medical, surgical, or gynaecological problems.\n5. Participants with a history of alcohol, tobacco dependence, or any other substance abuse\n6. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.\n7. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.\n8. Participants with demonstrated inability to comply with the study procedures, including poor compliance.\n9. Participants with inability to attend follow-up visits.\n10. Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions.\n11. Patients who had participated in other clinical trials during the previous 3 months.\n12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.","FEMALE","20 Years","50 Years",{"count":59,"type":22},60,[25],"This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.",[63,64],"Sexual Wellness","Women Health",[66,67],"dietary supplement","shatavari",{"date":38,"type":39},{"date":41,"type":22},{"date":43,"type":22},{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":55,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100626858","efficacy-and-safety-of-shatavari-root-extract-for-premenstrual-syndrome-in-women-100626858","NCT07441096","Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women","Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study","Inclusion Criteria:\n\n1. Healthy women aged 18-40 years with intact uterus and ovaries.\n2. Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.\n3. PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.\n4. Body mass index 18-35 kg\u002Fm2.\n5. Subject who has given written informed consent to participate in the study and understand the nature of the study.\n6. Able to read and write in English or any other vernacular language.\n7. No plan to commence new treatments over the study period.\n8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.\n\nExclusion Criteria:\n\n* 1\\. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability \\>7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.","40 Years",{"count":59,"type":22},[25],"Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life.\n\nThis study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.",[84,64],"Premenstrual Syndrome",[86,87,88],"PMS","Shatavari","Asparagus racemosus","NOT_YET_RECRUITING","2026-02-28",{"date":92,"type":39},"2026-03-03",{"date":94,"type":22},"2026-03-20",{"date":96,"type":22},"2026-07-08",{"name":45,"class":46},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":16,"sex":55,"minAge":79,"maxAge":19,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":47},"100626859","shatavari-root-extract-for-perimenopausal-symptoms-100626859","NCT07441109","Shatavari Root Extract for Perimenopausal Symptoms","Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study","Inclusion Criteria:\n\n1. Menopausal women aged \\>40 to 45 years with intact uterus and ovaries.\n2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.\n3. Females with complaints of at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness\n4. Body mass index 18-35 kg\u002Fm2\n5. Subject who has given written informed consent to participate in the study and understand the nature of the study.\n6. Able to read and write in English or any other vernacular language.\n7. No plan to commence new treatments over the study period.\n8. Must have the ability and willingness to si\n\nExclusion Criteria:\n\n1. Participants taking any form of herbal extract in the last 3 months before study entry.\n2. Participants who are on hormone replacement therapy (HRT) for more than 3 months.\n3. Participants who are pregnant.\n4. Participants with present active medical, surgical, and gynaecological problems.\n5. Participants with a history of alcohol, tobacco dependence, or any substance abuse.\n6. Participants who had undergone bilateral ovariectomy\n7. Participants with history of breast or cervical carcinoma\n8. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.\n9. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.\n10. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.\n11. Participants with evidence of demonstrated inability to follow study protocols or attend follow-up visits, including poor compliance.\n12. Participants with demonstrated inability to follow study protocols or attend follow-up visit\n13. Participants with inability to attend follow-up visit\n14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.\n15. Patients who had participated in other clinical trials during the previous 3 months.\n16. Patients who have any clinical condition, according to the investigator, who does not allow safe fulfilment of clinical trial protocol.",{"count":59,"type":22},[25],"This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract in women experiencing perimenopausal symptoms. Participants will receive either Shatavari root extract or a matched placebo for 12 weeks. Efficacy will be assessed using validated menopause-specific symptom, quality-of-life, stress, mood, and sleep questionnaires, along with physiological stress markers. Safety will be evaluated through laboratory assessments and adverse event monitoring.",[109,64],"Perimenopause",[87,111],"Dietary Supplement",{"date":92,"type":39},{"date":114,"type":22},"2026-03-11",{"date":116,"type":22},"2026-06-29",{"name":45,"class":46},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":47},"100625358","an-8-week-study-evaluating-gut-and-digestive-health-after-use-of-a-dietary-supplement-system-100625358","NCT07421596","An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System","An Eight-week Clinical Study for the Measurement of Gut and Digestive Health Parameters Before and After the Use of a Dietary Supplement System","Inclusion Criteria:\n\n* 1\\. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening.\n\n  2\\. Willing and able to provide written informed consent before participation in any study-related procedures.\n\n  3\\. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.\n\n  4\\. Willing to collect and provide stool samples, either in-clinic or at home as instructed.\n\n  5\\. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.\n\n  6\\. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone.\n\n  8\\. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.\n\n  9\\. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol.\n\n  11\\. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.\n\n  2\\. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to:\n  * Malabsorption disorders\n  * Chronic gastrointestinal diseases\n  * Severe depression\n  * Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report.\n\n    4\\. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception.\n\n    5\\. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment.\n\n    8\\. History of weight loss surgery or any type of bowel surgery, including resection or colectomy.\n\n    9\\. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.\n\n    10\\. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.\n\n    11\\. History of seizure disorder or use of seizure medication within the past 4 weeks.\n\n    12\\. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to:\n  * Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)\n  * Laxatives or gastrointestinal motility agents\n  * Medications for irritable bowel syndrome (IBS), Crohn's disease, or history of hospitalized diverticulitis 14. Any other condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation or compromise subject safety or study integrity.","80 Years",{"count":127,"type":22},50,[25],"This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period.\n\nGut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being.\n\nIn this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires.\n\nStool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being.\n\nThe study will also monitor the safety and tolerability of the dietary supplement system during the study period.",[131,132,133],"Gastrointestinal Symptoms","Digestive Health","Gut Health",[135,136,137,138],"Stool biomarkers","Probiotics","Subjective digestive health","Gut Zoomer stool test","2026-02-22",{"date":141,"type":39},"2026-02-24",{"date":143,"type":22},"2026-02-05",{"date":145,"type":22},"2026-04-21",{"name":45,"class":46},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":16,"sex":17,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":47},"100622555","a-study-of-a-dietary-supplement-on-serum-biomarkers-in-children-100622555","NCT07385144","A Study of a Dietary Supplement on Serum Biomarkers in Children","A Pilot Study Evaluating the Effects of a Dietary Supplement on Serum Biomarkers in Children","Inclusion Criteria:\n\n* Healthy Male and Females aged 4 - 15 years\n* NORMAL BMI \u002Fgrowth (per CDC growth tables) Between 5th - 85th percentile.\n* Able to read, understand, and complete the study questionnaire and records.\n* Able to understand the study procedures.\n* Able to comply with all study requirements.\n* Written informed consent\u002FAssent to participate in the study.\n* Agrees to maintain current lifestyle habits (diet, physical activity, medications, and sleep) as much as possible throughout the study and avoid taking new supplements\n* Willingness to actively participate in the study and to come to the scheduled visits.\n\nExclusion Criteria:\n\n* Immune insufficiency\n* Use of systemic corticosteroids or immunosuppressant drugs.\n* Any diseases or medications that might directly interfere in the study or put the subject's health under risk.\n* Currently taking any prescription medications or any dietary supplements including multivitamins\n* Employees of the institute or the brand owner or the manufacturers of the product\n* Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,","4 Years","15 Years",{"count":157,"type":22},30,[25],"This is a pilot clinical study designed to evaluate the effects of a dietary supplement on selected blood-based nutritional biomarkers in healthy children aged 4 to 15 years.\n\nApproximately 24 children will be screened and enrolled to account for potential dropouts, with a target of 20 participants completing the study. Eligible participants will attend a screening and baseline visit, followed by daily intake of the study supplement for 4 weeks. After the supplementation period, participants will return to the clinic for an end-of-study visit.\n\nBlood samples will be collected at baseline and after 4 weeks to measure nutritional biomarkers, including vitamin D, vitamin B12, folate, omega-3 fatty acids, and standard blood count parameters. Additional assessments include height, weight, body mass index (BMI), and a socioeconomic questionnaire. Throughout the study, participants or their caregivers will record daily supplement intake, any medications taken, and any adverse events in a study diary.\n\nThe results of this pilot study will provide preliminary data on the effects of the dietary supplement on serum biomarkers in children.",[161,162],"Nutritional Status","Serum Biomarkers",[111,164,165,166,167,168,169],"Pediatric Nutrition","Nutritional Biomarkers","Vitamins","Omega-3 Fatty Acids","Vitamin D","Vitamin B12","2026-02-02",{"date":172,"type":39},"2026-02-04",{"date":174,"type":22},"2026-01-30",{"date":176,"type":22},"2026-03-05",{"name":45,"class":46},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":16,"sex":17,"minAge":79,"maxAge":125,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":194,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":206,"locationsCount":47},"100609908","effects-of-sabroxy-supplementation-on-insulin-resistance-and-cognitive-function-in-adults-with-mild-cognitive-impairment-and-insulin-resistance-100609908","NCT07220694","Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairment and Insulin Resistance","An 8-week Study Evaluating the Effects of a Dietary Supplement (Sabroxy®) on Insulin Resistance and Cognitive Function in Subjects With Mild Cognitive Impairment and Insulin Resistance","Inclusion Criteria:\n\n1. Female or male, adults grouped by age as follows 2 groups of 70 patients each (35 active and 35 placebo )\n\n   * GROUP 1 = aged 40 - 60, and\n   * GROUP 2 = aged 61 - 80\n2. In good general health\n3. Screening HOMA-IR value ≥ 2.0 to \\\u003C 4.0\n4. Screening fasting glucose 100 to 135 mg\u002FdL\n5. Screening MoCA less than 26\n\nExclusion Criteria:\n\n1. Having been diagnosed with known allergies to any ingredients in the study product.\n2. Relevant history or presence of any medical disorder potentially interfering with this study (e.g., malabsorption, chronic gastrointestinal diseases, severe depression, cardiovascular disease occurrence within the last 3 months, etc.),\n3. Regular intake of medications or supplements known to affect glucose tolerance\n4. Breastfeeding, pregnant, or planning to become pregnant during the study, according to the subject's self-report.\n5. Having a pregnant partner or a partner who is planning to become pregnant during the study period or is unwilling or unable to use an acceptable method of contraception.\n6. Having a history of skin cancer within the past 5 years.\n7. Having a history of immunosuppression\u002Fimmune deficiency disorders (including HIV infection, it has been AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), or currently using oral or systemic immunosuppressive medications and biologics (e.g., azathioprine, belimumab, Cimzia®, Cosentyx®, cyclophosphamide, cyclosporine, Enbrel®, Humira®, Imuran®, Kineret®, mycophenolate mofetil, methotrexate, Orencia®, prednisone, Remicade®, Rituxan®, Siliq™, Simponi®, Stelara®, Taltz®) and\u002For undergoing radiation or chemotherapy as determined by study documentation.\n8. Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, halcinonide, and halobetasol).\n9. Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.\n10. Having started a long-term medication within the last 2 months.\n11. Having planned surgeries or invasive medical procedures during the study. Non-invasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.\n12. Currently participating in any other clinical trial at SFRI or another research facility or doctor's office.\n13. Having participated in any other clinical trial that evaluates or applies interventions to the same body system, organ, or condition being studied in this trial within 12 weeks prior to the screening visit at SFRI or another research facility or doctor's office.\n14. Note - Medications for treatment of chronic diseases that do not affect the metabolism of the study product will be permitted and will be judged individually regarding interference with the study by an investigator.",{"count":186,"type":22},140,[25],"This randomized, double-blind, placebo-controlled, 8-week clinical trial is designed to evaluate the effects of Sabroxy®, a standardized extract of Oroxylum indicum bark, on insulin resistance and cognitive function in adults with mild cognitive impairment and insulin resistance.\n\nA total of 120 participants (men and women, aged 40-80 years) who are non-smokers, with fasting glucose levels between 100-135 mg\u002FdL, HOMA-IR value ≥ 2.0 to \\\u003C 4.0, and a Montreal Cognitive Assessment (MoCA) score below 26, will be enrolled. Eligible participants will be randomized (1:1) to receive either Sabroxy® (250 mg with 5 mg BioPerine®) or placebo, administered orally once daily for 8 weeks.\n\nThe primary endpoint is the change in insulin resistance from baseline to Week 8, assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).\n\nThe secondary endpoints include changes in:\n\nCognitive performance, assessed using the Immediate Word Recall, Numeric Working Memory, Cognitive Failures Questionnaire (CFQ), and Montreal Cognitive Assessment (MoCA).\n\nBiomarkers of metabolic and neuronal function, including Brain-Derived Neurotrophic Factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), fasting insulin, fasting glucose, and phosphorylated tau\u002Famyloid beta (p-Tau\u002FAβ) ratio.\n\nSafety will be assessed through adverse event monitoring, vital signs, and routine clinical laboratory tests.\n\nThe study will be conducted at a single site, San Francisco Research Institute (USA), in compliance with the Declaration of Helsinki, ICH-GCP guidelines, and 21 CFR Part 312 (where applicable).\n\nThis study seeks to generate clinical evidence supporting the potential of Sabroxy® supplementation to improve glucose tolerance, reduce inflammation, and enhance cognitive function in individuals with early metabolic and neurocognitive dysfunctions.",[190,191,192,193],"Insulin Resistance","Mild Cognitive Impairment","Cognitive Decline","Neurodegenerative Disorders",[195,196,197,198,199],"BioPerine","Insulin Sensitivity","Cognitive Function","Memory Performance","Sabroxy","2026-01-26",{"date":202,"type":39},"2026-01-28",{"date":204,"type":22},"2026-01-29",{"date":41,"type":22},{"name":45,"class":46},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":47},"100609523","effects-of-ksm-66-ashwagandha-300-mg-on-skin-and-hair-health-in-healthy-men-and-women-100609523","NCT07215689","Effects of KSM-66 Ashwagandha® (300 mg) on Skin and Hair Health in Healthy Men and Women\"","A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Effects of KSM- 66 Ashwagandha® Capsule (300 mg) on Skin and Hair Health in Healthy Men and Women","Inclusion Criteria:\n\n1. Healthy adult men and women participants ≥ 18 years and ≤60 years of age.\n2. Willingness to follow the protocol requirements as evidenced by written informed consent.\n3. Participants who were on consistent dietary, hair, and skin product 3 months prior to start of the study and are willing to follow the same during the study.\n4. Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.\n5. Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.\n6. Willing to come for all follow-up visits.\n7. Participants who agree not to cut hair for the entire duration of the study.\n8. Participants willing to undergo Trichoscan evaluation and not to wash their hair 48 hours before the visit.\n9. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.\n10. Participants who agree to take investigational product (i.e., Till Day 90 ± 4 ± 4).\n\nExclusion Criteria:\n\n1. Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.\n2. Participants on any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.\n3. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to study medication).\n4. Participants who have undergone or plan to undergo hair transplantation surgery during the study period.\n5. Participants with facial skin cancer.\n6. Participants with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results.\n7. Participants with severe seborrheic dermatitis, alopecic disease, except for androgenic alopecia, and scalp disorders, such as scalp psoriasis and infection.\n8. Participants who have participated in a clinical study during the preceding 180 days.\n9. Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).\n10. Pregnant and lactating females\n11. Participants with alcohol addiction or persistent abuse of drugs of dependence.","60 Years",{"count":127,"type":22},[25],"Hair and skin play major roles in protecting the body, and maintaining their health is essential. Poor hair and skin health have become increasingly common due to the stress associated with modern lifestyles. Effective and time-efficient treatments for hair and skin health remain limited. Although hair loss, baldness, and skin issues are not life-threatening, managing these conditions is important because of the psychological and social complications-such as anxiety and depression-they can cause. There is an unmet need for therapies that provide safe and long-term improvements in hair and skin health.\n\nMany individuals seek Complementary and Alternative Medicine (CAM) to identify natural and effective options for these conditions. Adaptogens such as Ashwagandha (Withania somnifera) have long been studied for their potential to reduce stress and modulate cortisol levels in the body. Reducing stress may help prevent inflammation, a common contributor to hair shedding and loss. Ashwagandha also contains antioxidants and amino acids that may strengthen the hair and minimize breakage. Traditionally, Ashwagandha has been recognized for its multiple health benefits, including support for hair and skin wellness. However, there remains limited scientific evidence to substantiate these traditional claims, underscoring the need for controlled clinical evaluation.",[219,220],"Skin Health","Hair Health","2025-10-10",{"date":223,"type":39},"2025-10-15",{"date":225,"type":39},"2025-07-11",{"date":227,"type":22},"2025-12-10",{"name":45,"class":46},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":47},"100571030","efficacy-and-safety-of-a-proprietary-blend-of-ashwagandha-root-extract-aqueous-in-adult-men-and-women-with-high-stress-and-anxiety-a-randomized-double-blind-three-arm-parallel-placebo-controlled-study-100571030","NCT06714942","Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study","Inclusion Criteria:\n\n1. Adults (male and female) aged between 18 and 65 years.\n2. Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).\n3. Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening\u002Frandomization visit.\n4. Perceived Stress Scale (PSS) score ≥13 at the screening\u002Frandomization visit.\n5. BMI between 20 and 35.\n6. No plan to commence new treatments over the study period.\n7. Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills are permissible.\n8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.\n2. Patients having a total score of less than 14 on HAM-A at screening.\n3. Patients currently (or within the past 4 weeks prior to screening) taking any over-the-counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3, etc.\n4. Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.\n5. Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).\n6. Patients who have an established practice of meditation and relaxation techniques for three or more months.\n7. Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.\n8. Patients with a history of alcohol, tobacco dependence, or any substance abuse.\n9. Pregnant and lactating women or suspected to be pregnant.\n10. Patients with known hypersensitivity to Ashwagandha.\n11. Patients who had participated in other clinical trials during the previous 3 months.\n12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.","65 Years",{"count":237,"type":22},51,[25],"This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.",[241,30],"Stress","2024-12-01",{"date":244,"type":39},"2024-12-04",{"date":246,"type":39},"2024-10-25",{"date":248,"type":22},"2025-01-21",{"name":45,"class":46},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":16,"sex":55,"minAge":19,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":47},"100571154","efficacy-and-safety-of-shatavari-for-treatment-of-menopausal-symptoms-in-women-a-randomized-double-blind-three-arm-parallel-placebo-controlled-study-100571154","NCT06716554","Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study","Inclusion Criteria:\n\n1. Menopausal women aged 45 to 65 years with intact uterus and ovaries.\n2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days\n3. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.\n4. Body mass index 18-35 kg\u002Fm2\n5. Subject who has given written informed consent to participate in the study and understand the nature of the study\n6. Able to read and write in English or any other vernacular language\n7. No plan to commence new treatments over the study period.\n8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Participants taking any form of herbal extract in the last 3 months before study entry.\n2. Participants who are on hormone replacement therapy (HRT) for more than 3 months.\n3. Participants with Present active medical, surgical, and gynaecological problems.\n4. Participants with a history of alcohol, tobacco dependence, or any substance abuse\n5. Participants who had undergone bilateral ovariectomy\n6. Participants with history of breast or cervical carcinoma\n7. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.\n8. Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult\n9. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study\n10. Participants with evidence of uncooperative attitude, including poor compliance.\n11. Participants with inability to attend follow-up visit\n12. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.\n13. Patients with known hypersensitivity to Ashwagandha.\n14. Patients who had participated in other clinical trials during the previous 3 months.\n15. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol","55 Years",{"count":237,"type":22},[25],"This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.",[261,262,263],"Menopause","Hot Flashes","Mood","2024-11-29",{"date":244,"type":39},{"date":267,"type":39},"2024-10-26",{"date":269,"type":22},"2025-01-20",{"name":45,"class":46},""]