[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639085":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":58,"armGroups":62,"interventions":79,"overallOfficials":58,"centralContacts":89,"locations":95,"responsibleParty":114,"collaborators":116,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":58,"eligibilityCriteria":135,"healthyVolunteers":132,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":58,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":97,"whyStopped":58,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":41},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Menstrual patterns during treatment and after discontinuation","Document the number of episodes of menstruation during the treatment and follow-up period","From enrollment, during the treatment of 6 months, and within 3 months after treatment",{"measure":14,"description":15,"timeFrame":16},"Sex hormone levels","Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).","from enrollment to the end of treatment at 6 months",{"measure":18,"description":19,"timeFrame":20},"Uterine volume","Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.","From enrollment to the end of treatment at 6 months",{"measure":22,"description":23,"timeFrame":20},"Quality of Life Score(36-Item Short Form Health Survey，SF 36)","The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.",{"measure":25,"description":26,"timeFrame":16},"Total ovarian volume","Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.",[28,32,35,38],{"measure":29,"description":30,"timeFrame":31},"Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)","Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome).","From enrollment to 3 months after the end of treatment",{"measure":33,"description":34,"timeFrame":31},"Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.","Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome).",{"measure":36,"description":37,"timeFrame":31},"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)","Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).",{"measure":39,"description":40,"timeFrame":31},"Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)","Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) . Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) . A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation",[42,45,49,52],{"measure":43,"description":44,"timeFrame":20},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","Participants were followed up at the hospital every 3 months during the treatment period. At each follow-up visit, adverse events (AEs) were documented, and their causality (relationship to the treatment) was assessed by the investigators. The severity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0",{"measure":46,"description":47,"timeFrame":48},"Serum alanine aminotransferase (ALT) levels were measured to assess liver function.","Serum alanine aminotransferase (ALT) levels were measured to assess liver function. Elevated ALT levels indicate hepatocellular injury (worse outcome).","From enrollment to 3 months after the end of treatment.",{"measure":50,"description":51,"timeFrame":31},"Renal function was assessed by measuring serum creatinine (SCr) levels","Renal function was assessed by measuring serum creatinine (SCr) levels. Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .",{"measure":53,"description":54,"timeFrame":31},"Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .","Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) . Total physical activity was calculated as metabolic equivalent of task (MET)-minutes per week, ranging from 0 to 14,280 MET-minutes\u002Fweek (theoretical maximum), with higher scores indicating greater physical activity levels (better outcome) . Total sitting time was recorded as minutes per week, ranging from 0 to 1,440 minutes\u002Fweek, with higher scores indicating more sedentary behavior (worse outcome) .",{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":58,"timePerspective":58,"maskingInfo":60},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":61,"maskingDescription":58,"whoMasked":58},"NONE",[63,69,75],{"label":64,"type":65,"description":66,"interventionNames":67},"Femoston group","ACTIVE_COMPARATOR","Femoston 2\u002F10 (estradiol 2mg \u002F dydrogesterone 10mg), 1 tablet daily.",[68],"Drug: Western medicine",{"label":70,"type":71,"description":72,"interventionNames":73},"Ba Zhen Yi Mu Pill and Ding Kun Dan group","EXPERIMENTAL","Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently.",[74],"Drug: traditional Chinese medicine",{"label":76,"type":71,"description":77,"interventionNames":78},"Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group","Participants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg \u002F dydrogesterone 10mg, 1 tablet daily) concurrently.",[74,68],[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":58},"DRUG","traditional Chinese medicine","traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）",[76,70],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":58},"Western medicine","Western medicine（Femoston 2\u002F10)",[76,64],[90],{"name":91,"role":92,"phone":93,"phoneExt":58,"email":94},"Yan Deng, Doctor","CONTACT","86+010-69158331","yanndeng@163.com",[96],{"facility":5,"status":97,"city":98,"state":58,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"RECRUITING","Beijing","100730","China","CN",{"type":103,"coordinates":104},"Point",[105,106],116.39723,39.9075,{"lat":106,"lon":105},[109,111],{"name":91,"role":92,"phone":110,"phoneExt":58,"email":94},"01069158331",{"name":112,"role":113,"phone":58,"phoneExt":58,"email":58},"Aijun Sun, Doctor","PRINCIPAL_INVESTIGATOR",{"type":115,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[117,119,121,123,126,128],{"name":118,"class":6},"Peking University Third Hospital",{"name":120,"class":6},"Dongfang Hospital Beijing University of Chinese Medicine",{"name":122,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"name":124,"class":125},"Shenyang Women's and Children's Hospital","UNKNOWN",{"name":127,"class":125},"Beijing University of Chinese Medicine Third Affiliated Hospital",{"name":129,"class":6},"Beijing University of Chinese Medicine","100639085","phase-4-the-research-of-integrated-traditional-chinese-and-western-medicine-on-hypothalamic-amenorrhea-100639085",false,"NCT07580950","The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea","Inclusion Criteria:\n\nDiagnostic criteria for functional hypothalamic amenorrhea\n\n1. primary or secondary amenorrhea\n2. Normal or low FSH levels, LH \\\u003C 5 IU\u002FL, E2 \\\u003C 50 pg\u002FmL\n3. Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of amenorrhea\n\nExclusion Criteria:\n\n1. Individuals who have used relevant medications within the past 3 months\n2. History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)\n3. Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients\n4. Lactating or pregnant women, or females within one year postpartum\n5. History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston\n6. Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).\n7. History of thromboembolic disease or thrombotic tendency.\n8. Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).","FEMALE","14 Years","40 Years",{"count":140,"type":141},210,"ESTIMATED","INTERVENTIONAL",[144],"PHASE4","This study aims to validate the efficacy and safety of the \"two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine\" through a nationwide randomized controlled clinical trial involving 210 cases. Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.",[147],"Functional Hypothalamic Amenorrhea",[147,149,150],"Integrated Traditional Chinese and Western Clinical Medicine","Randomized controlled trial","2026-05-05",{"date":153,"type":154},"2026-05-12","ACTUAL",{"date":156,"type":154},"2025-10-22",{"date":158,"type":141},"2028-06-30",{"name":5,"class":6},1]