Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT03546595
Status:
UNKNOWN
Last Update Posted:
2019-12-26
First Post:
2018-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-23', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostasis model assessment-insulin resistance (HOMA-IR)', 'timeFrame': '3 month', 'description': 'HOMA-IR was calculated as \\[Plasma glucose (GLU,mmol/L)\\* serum insulin (mIU/L)\\] / 22.5.'}], 'secondaryOutcomes': [{'measure': 'Testosterone(T)', 'timeFrame': '3 month'}, {'measure': 'Androstadienedione (AND)', 'timeFrame': '3 month'}, {'measure': 'Sex hormone-binding globulin (SHBG)', 'timeFrame': '3 month'}, {'measure': 'Dehydroepiandrosterone sulfate (DHEAS)', 'timeFrame': '3 month'}, {'measure': 'Follicle stimulating hormone (FSH)', 'timeFrame': '3 month'}, {'measure': 'Luteinizing hormone (LH)', 'timeFrame': '3 month'}, {'measure': 'Estradiol (E2)', 'timeFrame': '3 month'}, {'measure': 'Weight', 'timeFrame': '3 month'}, {'measure': 'Waist/hip circumference', 'timeFrame': '3 month'}, {'measure': 'BMI', 'timeFrame': '3 month'}, {'measure': 'FG score', 'timeFrame': '3 month'}, {'measure': 'Acne', 'timeFrame': '3 month'}, {'measure': 'Short-Form Health Survey (SF-36)', 'timeFrame': '3 month'}, {'measure': 'The Chinese Quality of Life questionnaire (ChQoL)', 'timeFrame': '3 month'}, {'measure': 'Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)', 'timeFrame': '3 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Insulin Resistance'], 'conditions': ['Polycystic Ovary Syndrome', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '31142530', 'type': 'DERIVED', 'citation': 'Li Y, Hou L, Wang Y, Xie L, Zhang M, Pan Z, Li Y, Ding Y, Sun M, Qu Y, Liu S. Auricular points acupressure for insulin resistance in overweight/obese women with polycystic ovary syndrome: protocol for a randomised controlled pilot trial. BMJ Open. 2019 May 28;9(5):e027498. doi: 10.1136/bmjopen-2018-027498.'}]}, 'descriptionModule': {'briefSummary': 'The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.\n\nAuricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged between 15 and 40 years.\n* Diagnosis of PCOS according to the modified Rotterdam criteria.\n* 2 years after menarche.\n* Body mass index (BMI) equal to or greater than 23 kg/m2.\n* IR is defined by the homeostaticmodel assessment (HOMA-IR: (fasting insulin (μU/mL)×fasting glucose (mmol/L))/22.5). A value ≥2.14 will be considered to be indicative of IR.\n* With no desire of children within 3 months.\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': 'NCT03546595', 'briefTitle': 'Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Heilongjiang University of Chinese Medicine'}, 'officialTitle': 'Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.', 'orgStudyIdInfo': {'id': 'AA for IR-PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auricular acupoints acupressure', 'interventionNames': ['Other: Auricular acupoints acupressure']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham auricular acupoints acupressure', 'interventionNames': ['Other: Sham auricular acupoints acupressure']}], 'interventions': [{'name': 'Auricular acupoints acupressure', 'type': 'OTHER', 'description': 'The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.', 'armGroupLabels': ['Auricular acupoints acupressure']}, {'name': 'Sham auricular acupoints acupressure', 'type': 'OTHER', 'description': 'The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.', 'armGroupLabels': ['Sham auricular acupoints acupressure']}]}, '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': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heilongjiang University of Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'Yan Li', 'investigatorAffiliation': 'Heilongjiang University of Chinese Medicine'}}}}