[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657689":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":35,"armGroups":50,"interventions":63,"overallOfficials":75,"centralContacts":94,"locations":35,"responsibleParty":102,"collaborators":35,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":35,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":35,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":128,"whyStopped":35,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":35},{"fullName":5,"class":6},"Dongzhimen Hospital, Beijing","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Anti-Miller's Tube Hormone（AMH）","The unit is ng\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay","before treatment and the first menstrual period 2-4 days after treatment",[14,17,20,23,26,29,33,37],{"measure":15,"description":16,"timeFrame":12},"Follicle-stimulating hormone（FSH）","The unit is mIU\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay.",{"measure":18,"description":19,"timeFrame":12},"Luteinizing hormone（LH）","The unit is mIU\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay.",{"measure":21,"description":22,"timeFrame":12},"Estrogen (E2)","The unit is pg\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay.",{"measure":24,"description":25,"timeFrame":12},"Progesterone (P)","The unit is ng\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, P were measured by radioimmunoassay.",{"measure":27,"description":28,"timeFrame":12},"Testosterone（T）","The unit is ng\u002FmL.Elbow vein blood was collected on an empty stomach, and after separating the serum, T were measured by radioimmunoassay.",{"measure":30,"description":31,"timeFrame":32},"antral follicle count（AFC）","Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses.","before treatment and on days 2-4 of the early follicular phase in the first post-treatment menstrual cycle",{"measure":34,"description":35,"timeFrame":36},"Traditional Chinese Medicine Score",null,"baseline and immediately after treatment",{"measure":38,"description":35,"timeFrame":36},"Modified Kupperman rating scale",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":35,"timePerspective":35,"maskingInfo":44},"RANDOMIZED","PARALLEL","A Stratified Block Group Randomized Controlled Study","TREATMENT",{"masking":45,"maskingDescription":35,"whoMasked":46},"DOUBLE",[47,48],"PARTICIPANT","INVESTIGATOR","This study was a multicenter, stratified block randomized, double-blind, double simulation clinical trial.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Guishen Yijing Granules Group","EXPERIMENTAL","Guishen Yijing Granules",[56],"Drug: Guishen Yijing Granules",{"label":58,"type":59,"description":60,"interventionNames":61},"coenzyme Q10 group","ACTIVE_COMPARATOR","coenzyme Q10",[62],"Drug: Coenzyme Q10 (drug)",[64,70],{"type":65,"name":54,"description":66,"armGroupLabels":67,"otherNames":68},"DRUG","This study was a stratified district group randomized, double-blind, double simulation clinical trial with GSYJ granules + coenzyme Q10 simulant in the test group and GSYJ granules simulant + coenzyme Q10 in the control group",[52],[69],"GSYJ",{"type":65,"name":71,"description":66,"armGroupLabels":72,"otherNames":73},"Coenzyme Q10 (drug)",[58],[74],"CoQ10",[76,80,83,85,87,89,92],{"name":77,"affiliation":78,"role":79},"Yun Shi, phD","Dongzhimen Hospital of Beijing University of Chinese Medicine","PRINCIPAL_INVESTIGATOR",{"name":81,"affiliation":82,"role":79},"Piwen Zhao","Beijing University of Chinese Medicine",{"name":84,"affiliation":78,"role":79},"Qiaohui Yang",{"name":86,"affiliation":78,"role":79},"Chunmei Wang",{"name":88,"affiliation":78,"role":79},"Xiaoxia Bao",{"name":90,"affiliation":91,"role":79},"Qingya Yan","DHaiyunongzhimen Hospital of Beijing University of Chinese Medicine",{"name":93,"affiliation":78,"role":79},"Haiyun Sun",[95,99],{"name":77,"role":96,"phone":97,"phoneExt":35,"email":98},"CONTACT","13717926522","zhyshiyun@126.com",{"name":100,"role":96,"phone":35,"phoneExt":35,"email":101},"Xiaoying Li, Master","lixiaoying64@163.com",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Shi Yun","Chief of Gynecology","100657689","early-phase-1-guishen-yijing-granules-for-diminished-ovarian-reserve-with-kidney-deficiency-syndrome-a-randomized-controlled-trial-100657689",false,"NCT07841548","Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial","A Randomized and Double-blind Clinical Trial of Guishen Yijing Granules on the Modulation of Ovarian Function in Patients With Diminished Ovarian Reserve","Inclusion Criteria:\n\n(1) fulfillment of the diagnostic criteria for diminished ovarian reserve; (2) fulfillment of the Traditional Chinese Medicine pattern differentiation criteria for kidney deficiency syndrome; (3) age between 25 and 45 years (25 ≤ age \\\u003C 45); (4) baseline follicle-stimulating hormone level between 10 and 25 IU\u002FL (10 IU\u002FL ≤ baseline FSH \\\u003C 25 IU\u002FL); and (5) voluntary provision of written informed consent after being fully informed of the study details.\n\nExclusion Criteria:\n\n(1) pregnancy or lactation; (2) comorbidities involving severe conditions of the cardiovascular, cerebrovascular, or hematopoietic systems, or malignant tumors; (3) primary amenorrhea or a family history of early menopause; (4) diminished ovarian reserve caused by ovarian or related surgery; (5) mental disorders or intellectual disability; (6) use of hormonal medications within the past 3 months; or (7) concurrent participation in other clinical trials.","FEMALE","25 Years","45 Years",{"count":117,"type":118},120,"ESTIMATED","INTERVENTIONAL",[121],"EARLY_PHASE1","This study is a multicenter, stratified block-randomized, double-blind, double-dummy clinical trial designed to evaluate the efficacy and safety of Guishen Yijing Granules in patients with diminished ovarian reserve (DOR) and kidney deficiency syndrome through multidimensional assessment of clinical outcomes before and after treatment.\n\nA total of 120 patients with DOR will be recruited from the gynecology outpatient departments of Dongzhimen Hospital, Beijing University of Chinese Medicine; Xiyuan Hospital, China Academy of Chinese Medical Sciences; and Beijing Chaoyang Hospital, Capital Medical University. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group, with 60 participants in each group.\n\nParticipants in the experimental group will receive Guishen Yijing Granules plus a coenzyme Q10 placebo, whereas those in the control group will receive coenzyme Q10 plus a Guishen Yijing Granules placebo. Treatment will begin on day 5 of the menstrual cycle. For participants with amenorrhea, treatment will begin after pregnancy has been excluded. Each treatment cycle will consist of 21 consecutive days of medication. If menstruation occurs after completion of a treatment cycle, the next treatment cycle will begin on day 5 of the subsequent menstrual cycle. If menstruation does not occur, participants will discontinue treatment for 7 days after pregnancy has been excluded and then begin the next treatment cycle according to the same regimen. Treatment will continue for three menstrual cycles; participants with amenorrhea will receive treatment for 3 months.\n\nOutcomes assessed before and after treatment will include basal serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels, anti-Müllerian hormone (AMH), antral follicle count (AFC), traditional Chinese medicine syndrome scores, and modified Kupperman Index scores. The study aims to evaluate the efficacy and safety of Guishen Yijing Granules and their effects on ovarian function in patients with DOR.",[124],"Diminished Ovarian Reserve (DOR)",[126,127,54],"Diminished Ovarian Reserve","Ovarian function","NOT_YET_RECRUITING","2026-09-20",{"date":131,"type":132},"2026-09-25","ACTUAL",{"date":134,"type":118},"2026-09-22",{"date":136,"type":118},"2027-12-31",{"name":104,"class":6}]