[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626858":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"SF Research Institute, Inc.","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Shatavari Root Extract","EXPERIMENTAL","Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks.",[13],"Dietary Supplement: Shatavari Root Extract",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Inactive capsule)","PLACEBO_COMPARATOR","Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks.",[19],"Other: Placebo Capsule",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Placebo Capsule","The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Dr. John Ademola","CONTACT","415-845-4638","jademola@sfinstitute.com",[38],{"facility":39,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"San Francisco Research Institute","San Francisco","California","94132","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.41942,37.77493,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":25,"email":55},"Komal Makwana","267-466-9000","komalk.sfinstitute@gmail.com",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[59],{"name":60,"class":61},"Ixoreal Biomed Private Limited","INDUSTRY","100626858","efficacy-and-safety-of-shatavari-root-extract-for-premenstrual-syndrome-in-women-100626858",false,"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.",true,"FEMALE","18 Years","40 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82],"Premenstrual Syndrome","Women Health",[84,85,86],"PMS","Shatavari","Asparagus racemosus","NOT_YET_RECRUITING","2026-02-28",{"date":90,"type":91},"2026-03-03","ACTUAL",{"date":93,"type":75},"2026-03-20",{"date":95,"type":75},"2026-07-08",{"name":5,"class":6},1]