[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572208":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":48,"locations":58,"responsibleParty":77,"collaborators":36,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":36,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":36,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Taichung Tzu Chi Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Danggui Shaoyao San","EXPERIMENTAL","Participants in this group will receive Danggui Shaoyao San, a traditional Chinese medicine (TCM) formula, for the treatment of primary dysmenorrhea. The medication will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. Danggui Shaoyao San is intended to regulate blood flow, reduce inflammation, and alleviate uterine contractions associated with dysmenorrhea.",[13],"Drug: Danggui Shaoyao San (DSS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cuscuta Chinensis","Participants in this group will receive Cuscuta Chinensis, a TCM formula commonly used to support kidney function and alleviate menstrual pain. The medication will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group aims to evaluate the efficacy of Cuscuta Chinensis in managing dysmenorrhea symptoms.",[18],"Drug: Cuscuta Chinensis (Tu Si Zi)",{"label":20,"type":10,"description":21,"interventionNames":22},"Danggui Shaoyao San + Cuscuta Chinensis","articipants in this group will receive a combination of Danggui Shaoyao San and Cuscuta Chinensis. The combined therapy will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group aims to assess whether the combination therapy provides enhanced efficacy in reducing pain and other menstrual symptoms compared to single interventions.",[23],"Drug: Combination Therapy (DSS + Tu Si Zi)",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo","PLACEBO_COMPARATOR","Participants in this group will receive a placebo that matches the study medications in appearance and packaging. The placebo will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group serves as a control to evaluate the specific effects of the active interventions on primary dysmenorrhea.",[29],"Drug: Placebo",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Danggui Shaoyao San (DSS)","Danggui Shaoyao San is a traditional Chinese medicine (TCM) formula used to regulate blood flow, alleviate pain, and reduce inflammation. Participants in this arm will receive DSS starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Cuscuta Chinensis (Tu Si Zi)","Cuscuta Chinensis is a TCM formula traditionally used to nourish kidney essence and improve menstrual health. Participants in this arm will receive Tu Si Zi starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Combination Therapy (DSS + Tu Si Zi)","This intervention combines Danggui Shaoyao San and Cuscuta Chinensis. Participants will receive both formulas starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.",[20],{"type":32,"name":25,"description":46,"armGroupLabels":47,"otherNames":36},"Participants in this arm will receive a placebo that matches the appearance of the study medications. The placebo will be administered on the same schedule as the active treatments for two menstrual cycles.",[25],[49,55],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Chia Ying Chuang, MD, MSc","CONTACT","+886-4-36060666","3272","jiainwhh@gmail.com",{"name":56,"role":51,"phone":52,"phoneExt":36,"email":57},"Dian-Kun Li, MD,","diankunli@gmail.com",[59],{"facility":5,"status":36,"city":60,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Taichung","427","Taiwan","TW",{"type":65,"coordinates":66},"Point",[67,68],120.6839,24.1469,{"lat":68,"lon":67},[71,74,76],{"name":72,"role":51,"phone":73,"phoneExt":53,"email":54},"Chia-Ying Chuang, MD, MSc","886-4-36060666",{"name":75,"role":51,"phone":52,"phoneExt":36,"email":57},"Dian-Kun Li, MD",{"name":75,"role":51,"phone":36,"phoneExt":36,"email":36},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Chia-Ying Chuang","Attending Physician, Department of Chinese Medicine, Taichung Tzu Chi Hospital","100572208","a-preliminary-study-on-the-efficacy-of-danggui-shaoyao-san-and-cuscuta-chinensis-in-patients-with-primary-dysmenorrhea-100572208",false,"NCT06730282","A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients with Primary Dysmenorrhea","Inclusion Criteria:\n\n1. Female participants aged 20 to 45 years.\n2. Regular menstrual cycles (21 to 42 days).\n3. History of moderate to severe primary dysmenorrhea (Visual Analogue Scale (VAS) score \\> 3) persisting for at least three consecutive menstrual cycles.\n4. Able to understand and complete the study questionnaires (e.g., MSQ).\n5. Willing to comply with study protocols, including taking study medications and attending follow-up visits.\n\nExclusion Criteria:\n\n1. Secondary dysmenorrhea caused by conditions such as endometriosis, pelvic inflammatory disease, or uterine fibroids.\n2. Current use of an intrauterine contraceptive device (IUD).\n3. Irregular menstrual cycles.\n4. Pregnant, breastfeeding, or planning pregnancy within the study period.\n5. Use of anticoagulant medications (e.g., aspirin, warfarin, or heparin).\n6. Known allergies to any components of the study medications.\n7. Severe uncontrolled systemic diseases (e.g., neurological disorders, immunodeficiency, or bleeding disorders).\n8. Concurrent use of other herbal medicines or alternative treatments for premenstrual syndrome or dysmenorrhea.\n9. Participation in another clinical trial during the study period.\n\n   \\-","FEMALE","20 Years","45 Years",{"count":91,"type":92},200,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study aims to evaluate the efficacy of two traditional Chinese medicine (TCM) formulas, Danggui Shaoyao San (DSS) and Cuscuta Chinensis (Tu Si Zi), in treating primary dysmenorrhea (PD). Primary dysmenorrhea, a common condition characterized by painful menstrual cramps, affects many women of reproductive age and significantly impacts their quality of life. Conventional treatments, such as NSAIDs and oral contraceptives, often have limited efficacy or side effects, underscoring the need for alternative therapeutic options.\n\nIn this randomized, double-blind study, participants will be divided into four groups: DSS, Tu Si Zi, a combination of DSS and Tu Si Zi, and a placebo group. The study will measure treatment outcomes using the Visual Analogue Scale (VAS) for pain and the Menstrual Symptom Questionnaire (MSQ), which captures physical and emotional symptoms. Additionally, TCM-based tools like pulse diagnosis and constitution questionnaires will be employed to explore personalized treatment strategies.\n\nThis research seeks to determine whether these TCM formulas can alleviate pain and improve other menstrual symptoms, potentially providing broader benefits than conventional painkillers. The findings aim to support evidence-based integration of TCM in managing dysmenorrhea and inform clinicians and patients about effective therapeutic choices.",[98,99],"Primary Dysmenorrhea (PD)","Traditional Chinese Medicine (TCM) Approaches",[101,102,33,38,103],"Primary Dysmenorrhea","Traditional Chinese Medicine (TCM)","Herbal Medicine","NOT_YET_RECRUITING","2024-12-11",{"date":107,"type":108},"2024-12-12","ACTUAL",{"date":110,"type":92},"2024-12-01",{"date":112,"type":92},"2026-06-30",{"name":5,"class":6},1]