[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605254":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":69,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TJAOA103","EXPERIMENTAL","Once enrolled, participants will be administered TJAOA103 for 4 to 12 weeks.",[13],"Drug: TJAOA103",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Once enrolled, participants will be administered TJAOA103 for 4 to 12 weeks. TJAOA103 should be taken orally twice a day, one sack each time. Dissolve it in about 200 mL of warm water and drink it all. Participants can take it half an hour before breakfast in the morning and half an hour before bedtime in the evening.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Jinjin Zhang, Associate Professor","CONTACT","+8613469995233","jinjinzhang@tjh.tjmu.edu.cn",[27],{"facility":28,"status":19,"city":29,"state":19,"zip":19,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","China","CN",{"type":33,"coordinates":34},"Point",[35,36],114.26667,30.58333,{"lat":36,"lon":35},[39,40],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":41,"role":23,"phone":19,"phoneExt":19,"email":42},"Yueyue Gao","2024tj0062@hust.edu.cn",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jinjin Zhang","Associate Professor","100605254","early-phase-1-a-clinical-study-of-chinese-herbal-formula-tjaoa103-in-treating-genitourinary-syndrome-of-menopause-100605254",false,"NCT07160127","A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause","The Efficacy and Safety of Chinese Herbal Formula TJAOA103 for the Treatment of Genitourinary Syndrome of Menopause: A Prospective and Single-Arm Study","Inclusion Criteria:\n\n1. Females aged 45-70 years during the menopausal transition or postmenopausal period.\n2. Presence of at least one moderate-to-severe (score ≥ 2) symptom of GSM, including vulvovaginal dryness, or vulvovaginal itching\u002Firritation, or vulvovaginal burning\u002Fpain, or dyspareunia, or dysuria\u002Furinary frequency\u002Furgency.\n3. Willing to participate in this trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Acute or recurrent genitourinary infection.\n2. Acute or chronic dermatosis of the vulva or vagina.\n3. A grade 3 or higher degree of prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.\n4. Unexplained abnormal uterine bleeding.\n5. Ovarian\u002Fadnexal mass ≥ 4 cm, or adenomyosis, or adenomyoma\u002Futerine myoma ≥ 4 cm.\n6. Breast Imaging Reporting and Data System (BI-RADS) classification of breast ultrasound ≥ 4.\n7. Presence of precancerous lesions or diagnosed malignancy.\n8. Liver or kidney function indicators (ALT, AST, Urea, Cr) exceeding the upper limits of reference ranges upon repeated testing.\n9. Severe primary diseases of the nervous, circulatory, respiratory, digestive, urinary or hematopoietic systems; or mental diseases;\n10. Known allergy to any specific ingredient of the trial drugs.\n11. Systemic hormone therapy within the past 2 months.\n12. Application of vaginal moisturizers, lubricants, hormone preparations, or alternative therapies for GSM within the past month.\n13. Current participation in another clinical trial or participation in another trial within the past month.\n14. Unwillingness to discontinue the use of moisturizers, lubricants, or any form of hormonal drugs during the trial.\n15. Other conditions deemed unsuitable for participation by the investigators.","FEMALE","45 Years","70 Years",{"count":58,"type":59},113,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","The goal of this clinical trial is to learn if Chinese herbal formula TJAOA103 works to treat genitourinary syndrome of menopause (GSM). It will also learn about the safety of TJAOA103. The main questions it aims to answer are:\n\n1. Does TJAOA103 alleviate the symptoms of GSM in participants or have any other benefits?\n2. What medical problems do participants have when taking TJAOA103? Researchers will conduct a pre-post comparison to see if TJAOA103 works to treat GSM.\n\nParticipants will:\n\n1. Take TJAOA103 twice daily for 4 to 12 weeks.\n2. Complete the tests and\u002For questionnaires on schedule through online follow-up or outpatient visits.\n3. Record their use of TJAOA103 and any adverse events.",[65],"Genitourinary Syndrome of Menopause (GSM)",[67,68],"Genitourinary Syndrome of Menopause","Traditional Chinise Medicine","NOT_YET_RECRUITING","2025-09-10",{"date":72,"type":73},"2025-09-17","ACTUAL",{"date":75,"type":59},"2025-09-15",{"date":77,"type":59},"2027-09-15",{"name":5,"class":6},1]