Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT03623451
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The fatty acid amides (FAAs) metabolite changes', 'timeFrame': '3 months', 'description': 'The metabolic changes before and after treatment'}], 'secondaryOutcomes': [{'measure': 'The sulfated steroids metabolite changes', 'timeFrame': '3 months', 'description': 'The metabolic changes before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a most common, heterogeneous, complex endocrinopathy disease.Traditional Chinese medicine (TCM) has been used in the treatment of PCOS for many years. However, the mechanism underlying TCM remains obscure and challenging.In the present study, a metabolomics approach based on ultra-high-performance liquid chromatography (UPLC) coupled with linear ion trap Orbi-trap mass spectrometer (LTQ Orbi-trap MS) is used to investigate serum metabolic changes of TCM intervention to PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003, PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\\>10 ml.\n* Age between 14 and 40 years.\n* 2 years after menarche\n\nExclusion Criteria:\n\n* Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.\n* Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.\n* Patients with known severe organ dysfunction or mental illness."}, 'identificationModule': {'nctId': 'NCT03623451', 'briefTitle': 'Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Heilongjiang University of Chinese Medicine'}, 'officialTitle': 'Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'Shen Qi Tiao Ti_PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese Medicine Formula', 'description': 'All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.', 'interventionNames': ['Drug: Chinese Medicine Formula']}], 'interventions': [{'name': 'Chinese Medicine Formula', 'type': 'DRUG', 'description': 'Chinese Medicine Formula, composed of American ginseng 10g, Poria cocos 15g, bighead atractylodes rhizome 20g, Astragalus mongholicus 30g, Crataegus pinnatifida Bunge 20g, Salvia miltiorrhiza Bge. 20g, Pericarpium Citri Reticulatae 10g will be decocted and packaged into vacuum packs by the pharmaceutical department of First Affiliated Hospital, Heilongjiang University of Chinese Medicine (140 mL/pack). Subjects will take 2 packages per day for three months.', 'armGroupLabels': ['Chinese Medicine Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150040', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heilongjiang University of Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Yan Li', 'investigatorAffiliation': 'Heilongjiang University of Chinese Medicine'}}}}