Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 9:11 PM
Study NCT ID:
NCT05976295
Status:
UNKNOWN
Last Update Posted:
2023-09-08
First Post:
2023-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovulation rate', 'timeFrame': '3 months', 'description': 'Ovulation rate in each group during the study period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The diagnosis of PCOS is based on the Rotterdam criteria.\n2. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in TCM theory.\n3. women aged 18-40 years without fertility requirements.\n4. A willingness to undergo this treatment plan.\n\nExclusion Criteria:\n\n1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).\n2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.\n3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.\n4. Suspected Cushing's syndrome.\n5. Adrenal or ovarian tumors secreting androgen.\n6. Poorly controlled type II diabetes.\n7. Pregnancy or lactation.\n8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).\n9. Those who had taken hormones or other drugs during the previous 3 months.\n10. Acute heart, liver, kidney or blood diseases."}, 'identificationModule': {'nctId': 'NCT05976295', 'briefTitle': 'Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Jiangxi University of Traditional Chinese Medicine'}, 'officialTitle': 'Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '20223BBG71012-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapy group', 'interventionNames': ['Drug: Jianpi Qushi Huatan Decoction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Jianpi Qushi Huatan Decoction', 'type': 'DRUG', 'description': 'The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months.', 'armGroupLabels': ['Therapy group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The control group will receive a placebo treatment.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Ruining', 'role': 'CONTACT', 'email': 'jack169@sina.com', 'phone': '0086-0791-88385243'}], 'facility': 'The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Liang Ruining', 'role': 'CONTACT', 'email': 'jack169@sina.com', 'phone': '0086-0791-88385243'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangxi University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Ruining Liang', 'investigatorAffiliation': 'Jiangxi University of Traditional Chinese Medicine'}}}}