[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657785":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":56,"studyPopulation":56,"armGroups":59,"interventions":70,"overallOfficials":56,"centralContacts":76,"locations":86,"responsibleParty":103,"collaborators":56,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":56,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":131,"whyStopped":56,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Dongzhimen Hospital, Beijing","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Serum Follicle-Stimulating Hormone (FSH)","Blood samples are collected before and after treatment.","From baseline to 3 months after treatment initiation",[14,16,18,21,23,27,30,33,35,37,39,41,43,45],{"measure":15,"description":11,"timeFrame":12},"Serum Anti-Müllerian Hormone (AMH) Level",{"measure":17,"description":11,"timeFrame":12},"Serum Luteinizing Hormone (LH)",{"measure":19,"description":20,"timeFrame":12},"FSH\u002FLH Ratio","Change in FSH\u002FLH ratio before and after treatment.",{"measure":22,"description":11,"timeFrame":12},"Serum Estradiol (E2)",{"measure":24,"description":25,"timeFrame":26},"Traditional Chinese Medicine Syndrome Score","This syndrome score evaluates three primary symptoms and twelve secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome.","before and 1 month after the treatment",{"measure":28,"description":29,"timeFrame":26},"Modified Kupperman Menopausal Index (KMI)","The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome.",{"measure":31,"description":32,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.",{"measure":34,"description":11,"timeFrame":12},"HO-1",{"measure":36,"description":11,"timeFrame":12},"NQO1",{"measure":38,"description":11,"timeFrame":12},"CAT",{"measure":40,"description":11,"timeFrame":12},"SOD",{"measure":42,"description":11,"timeFrame":12},"MDA",{"measure":44,"description":11,"timeFrame":12},"FTO",{"measure":46,"description":11,"timeFrame":12},"m6a",[48],{"measure":49,"description":50,"timeFrame":12},"Pregnancy Rate","The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.",{"allocation":52,"interventionModel":53,"interventionModelDescription":54,"primaryPurpose":55,"observationalModel":56,"timePerspective":56,"maskingInfo":57},"NON_RANDOMIZED","PARALLEL","This is a non-randomized, parallel-group interventional study consisting of a POI treatment group and a healthy control group. Participants with POI will receive Jiajian Guishen Optimized Formula for three menstrual cycles and undergo assessments before and after treatment. Healthy controls will receive no intervention and undergo a single assessment at enrollment.","TREATMENT",null,{"masking":58,"maskingDescription":56,"whoMasked":56},"NONE",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"JJGS treatment group","EXPERIMENTAL","JJGS is a traditional Chinese medicine formula administered to patients with POI for three menstrual cycles. Blood samples will be collected before and after treatment.",[65],"Drug: JJGS",{"label":67,"type":68,"description":69,"interventionNames":56},"Healthy control group","NO_INTERVENTION","healthy people",[71],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":56},"DRUG","JJGS","JJGS is a traditional Chinese medicine formulation. Patients with POI will receive the formula for three menstrual cycles, and blood samples will be collected before and after treatment. Participants in the healthy control group will receive no intervention, and their blood samples will be collected at enrollment.",[61],[77,82],{"name":78,"role":79,"phone":80,"phoneExt":56,"email":81},"Yun Shi","CONTACT","+8613717926522","zhyshiyun@126.com",{"name":83,"role":79,"phone":84,"phoneExt":56,"email":85},"Xiyu Li","+8619212951890","18165120161@163.com",[87],{"facility":88,"status":56,"city":89,"state":56,"zip":56,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Dongzhimen Hospital, Beijing University of Chinese Medicine","Beijing","China","CN",{"type":93,"coordinates":94},"Point",[95,96],116.39723,39.9075,{"lat":96,"lon":95},[99],{"name":100,"role":79,"phone":101,"phoneExt":56,"email":102},"Xueting Han","+861084012709","dzmyyec@126.com",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"SPONSOR_INVESTIGATOR","Shi Yun","Head of Gynecology","100657785","early-phase-1-effect-and-mechanism-of-jiajian-guishen-optimized-formula-on-premature-ovarian-insufficiency-insights-into-m6a-modification-and-oxidative-stress-100657785",false,"NCT07843030","Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress","JJGS ; POI","Inclusion Criteria:\n\nInclusion Criteria for Participants with POI: 1. Meeting the Western medicine diagnostic criteria for premature ovarian insufficiency (POI); 2. Meeting the traditional Chinese medicine diagnostic criteria for the kidney deficiency and liver stagnation syndrome; 3. Aged 18-39 years; 4. Willing and able to provide written informed consent. Participants must meet all four criteria to be included.\n\nInclusion Criteria for Healthy Participants: 1. Aged 18-39 years; 2. Regular menstrual cycles; 3. Normal sex hormone and anti-Müllerian hormone (AMH) levels; 4. Willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\nExclusion Criteria for Participants with POI: 1. Congenital gonadal dysgenesis or a family history of premature menopause; 2. POI caused by acquired organic disease or ovarian surgery; 3. Treatment with artificial menstrual cycle therapy or other hormonal therapy within the previous three months; 4. Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders; 5. Known allergy to any component of the study medication. Participants meeting any of the above criteria will be excluded.\n\nExclusion Criteria for Healthy Participants: The same as criteria 1, 3, 4, and 5 above.",true,"FEMALE","18 Years","39 Years",{"count":119,"type":120},45,"ESTIMATED","INTERVENTIONAL",[123],"EARLY_PHASE1","The goal of this clinical study is to evaluate the effectiveness of JiaJian GuiShen Optimized Formula (JJGS) and explore its mechanisms involving m6A modification and oxidative stress in women with premature ovarian insufficiency (POI). The main question it aims to answer is:\n\nDoes JJGS improve ovarian function in women with POI after three menstrual cycles of treatment? Twenty-five women with POI will receive JJGS, and 20 healthy women will serve as controls. Changes in FSH, E2, LH, AMH, oxidative stress markers, plasma FTO levels, whole-blood RNA m6A levels, and symptom scores will be analyzed before and after treatment.",[126],"Premature Ovarian Insufficiency",[128,129,130],"premature ovarian insufficiency","traditional Chinese medicine","oxidative stress","NOT_YET_RECRUITING","2026-09-21",{"date":134,"type":135},"2026-09-25","ACTUAL",{"date":137,"type":120},"2026-09-30",{"date":139,"type":120},"2027-03-30",{"name":105,"class":6},1]