Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 8:48 AM
Study NCT ID:
NCT05021094
Status:
UNKNOWN
Last Update Posted:
2022-09-09
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620717', 'term': 'kuntai capsule'}, {'id': 'C472241', 'term': 'femoston'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004394', 'term': 'Dydrogesterone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-04', 'size': 253689, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-23T07:39', 'hasProtocol': True}, {'date': '2021-08-04', 'size': 137357, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-23T07:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'blind experiment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Subclinical POI and POI patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follicle-stimulating hormone (FSH)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Changes of the level of FSH before and after treatment'}, {'measure': 'Kupperman Score', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Changes of the Kupperman score before and after treatment，Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject'}], 'secondaryOutcomes': [{'measure': 'Luteinizing hormone (LH)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Changes of the level of LH before and after treatment'}, {'measure': 'Estradiol hormone (E2)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Changes of the level of Estradiol hormone before and after treatment'}, {'measure': 'Antral follicle count (AFC)', 'timeFrame': 'Baseline, 3 months,', 'description': 'Changes of the AFC before and after treatment'}, {'measure': 'anti-Müllerian hormone (AMH)', 'timeFrame': 'Baseline, 3 months,', 'description': 'Changes of the level of AMH before and after treatment'}, {'measure': 'The peak systolic blood flow velocity （PSV）', 'timeFrame': 'Baseline, 3 months,', 'description': 'The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound'}, {'measure': 'The end-diastolic blood flow velocity（EDV）', 'timeFrame': 'Baseline, 3 months,', 'description': 'The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound'}, {'measure': 'Uterine artery resistance index（RI）', 'timeFrame': 'Baseline, 3 months,', 'description': 'The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound'}, {'measure': 'Proportion of patients with normal menstruation', 'timeFrame': 'Baseline，3 months, 6 months, 9 months', 'description': 'To measure the ratio of patients have normal menstruation after treatment'}, {'measure': 'Pregnancy situation', 'timeFrame': '6 months', 'description': 'To ask the patient if there is pregnancy (for patient who has pregnancy need)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Ovarian Insufficiency']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).', 'detailedDescription': 'The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The women aged \\<40 years old.\n2. Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions \\>4 weeks apart). Rare menstruation or menopause for at least 4 months.\n3. Individuals meeting the above criteria who voluntarily consented to study participation.\n\nExclusion Criteria:\n\n1. Pregnant and lactating patients;\n2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \\> 4cm or hysterectomy;\n3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;\n4. Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index \\> 30 kg/m2, smoking and family history of thrombosis);\n5. Patients with porphyria;\n6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;\n7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;\n8. Patients who suspect or have a history of alcohol and drug abuse;\n9. Patients who are known to be allergic to the test drugs or their components;\n10. The researchers determined that patients are not suitable for this trial.'}, 'identificationModule': {'nctId': 'NCT05021094', 'briefTitle': 'Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nantong University'}, 'officialTitle': 'A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function', 'orgStudyIdInfo': {'id': 'AHNantong-POI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POI patients who taking Kuntai capsule', 'description': 'Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.', 'interventionNames': ['Drug: Kuntai Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'POI patients who accepting hormone therapy', 'description': 'The estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken.', 'interventionNames': ['Drug: Femoston']}, {'type': 'EXPERIMENTAL', 'label': 'POI patients who taking Kuntai capsule combined with hormone therapy', 'description': 'Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.', 'interventionNames': ['Drug: Kuntai Capsule', 'Drug: Femoston']}, {'type': 'EXPERIMENTAL', 'label': 'Subclinical POI patients who taking Kuntai capsule', 'description': 'Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment', 'interventionNames': ['Drug: Kuntai Capsule']}], 'interventions': [{'name': 'Kuntai Capsule', 'type': 'DRUG', 'otherNames': ['Kuntai Jiaonang'], 'description': 'The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study.', 'armGroupLabels': ['POI patients who taking Kuntai capsule', 'POI patients who taking Kuntai capsule combined with hormone therapy', 'Subclinical POI patients who taking Kuntai capsule']}, {'name': 'Femoston', 'type': 'DRUG', 'otherNames': ['Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets'], 'description': 'The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study.', 'armGroupLabels': ['POI patients who accepting hormone therapy', 'POI patients who taking Kuntai capsule combined with hormone therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '226600', 'city': 'Hai’an', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Lu, master', 'role': 'CONTACT', 'phone': '13862711105'}], 'facility': "Hai'an People's Hospital", 'geoPoint': {'lat': 32.54361, 'lon': 120.45}}, {'zip': '226600', 'city': "Huai'an", 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Chen, master', 'role': 'CONTACT', 'phone': '18934506298'}], 'facility': "Hai'an Hospital of traditional Chinese Medicine", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'zip': '226001', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanli Zheng, Master', 'role': 'CONTACT', 'phone': '+8613962910099'}], 'facility': "Nantong First People's Hospital", 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '226001', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongmei C Chen, Master', 'role': 'CONTACT', 'phone': '13485105619'}], 'facility': 'Nantong Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanquan Zhang, Professor', 'role': 'CONTACT', 'email': 'jsnt_zhangyuquan@163.com', 'phone': '+8613706299363'}], 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '226500', 'city': "Ru'gao", 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sifang Zhang, bachelor', 'role': 'CONTACT', 'phone': '18752861616'}], 'facility': 'Rugao Boai Hospital'}], 'centralContacts': [{'name': 'Yuquan Zhang, Professor', 'role': 'CONTACT', 'email': 'jsnt_zhangyuquan@163.com', 'phone': '+8613706299363'}, {'name': 'Weina Wang, Postgraduate', 'role': 'CONTACT', 'email': '451579895@qq.com', 'phone': '13795242689'}], 'overallOfficials': [{'name': 'Yuquan Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Nantong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning sharing at present.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Obstetrics and Gynaecology', 'investigatorFullName': 'Yuquan Zhang', 'investigatorAffiliation': 'Affiliated Hospital of Nantong University'}}}}