Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT03450902
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incontinence episode per 24 h', 'timeFrame': '8 week (post-treatment) and 12 week (follow-up)', 'description': 'assessed by 72 h bladder diary'}], 'secondaryOutcomes': [{'measure': 'Change in ICIQ-SF questionnaire', 'timeFrame': '8 week (post-treatment) and 12 week (follow-up)', 'description': 'assessed by ICIQ-SF questionnaire'}, {'measure': 'Change in I-QOL questionnaire', 'timeFrame': '8 week (post-treatment) and 12 week (follow-up)', 'description': 'assessed by I-QOL questionnaire'}, {'measure': 'proportion of participants with more than 50% improvement in incontinence episodes per 24h', 'timeFrame': '8 week (post-treatment)', 'description': 'assessed by 72 h bladder diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary incontinence, Chinese herb, Acupuncture'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.', 'detailedDescription': 'This factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture.\n\nTo minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary\n\nExclusion Criteria:\n\n* (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.'}, 'identificationModule': {'nctId': 'NCT03450902', 'briefTitle': 'Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence', 'orgStudyIdInfo': {'id': 'Z161100000516156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herb & acupuncture', 'description': 'Participants will take Yiqi Suoquan granule and receive acupuncture.', 'interventionNames': ['Combination Product: Chinese herb & sham acupuncture', 'Combination Product: Placebo & acupuncture', 'Other: Placebo & sham acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chinese herb & sham acupuncture', 'description': 'Participants will take Yiqi Suoquan granule and receive sham acupuncture.', 'interventionNames': ['Combination Product: Chinese herb & acupuncture', 'Combination Product: Placebo & acupuncture', 'Other: Placebo & sham acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo & acupuncture', 'description': 'Participants will take placebo granule and receive acupuncture.', 'interventionNames': ['Combination Product: Chinese herb & acupuncture', 'Combination Product: Chinese herb & sham acupuncture', 'Other: Placebo & sham acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo & sham acupuncture', 'description': 'Participants will take placebo granule and receive sham acupuncture.', 'interventionNames': ['Combination Product: Chinese herb & acupuncture', 'Combination Product: Chinese herb & sham acupuncture', 'Combination Product: Placebo & acupuncture']}], 'interventions': [{'name': 'Chinese herb & acupuncture', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Yiqi Suoquan granule & acupuncture'], 'description': "Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.", 'armGroupLabels': ['Chinese herb & sham acupuncture', 'Placebo & acupuncture', 'Placebo & sham acupuncture']}, {'name': 'Chinese herb & sham acupuncture', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Yiqi Suoquan granule & sham acupuncture'], 'description': "Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.", 'armGroupLabels': ['Chinese herb & acupuncture', 'Placebo & acupuncture', 'Placebo & sham acupuncture']}, {'name': 'Placebo & acupuncture', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['placebo granule & acupuncture'], 'description': "Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.", 'armGroupLabels': ['Chinese herb & acupuncture', 'Chinese herb & sham acupuncture', 'Placebo & sham acupuncture']}, {'name': 'Placebo & sham acupuncture', 'type': 'OTHER', 'otherNames': ['placebo granule & sham acupuncture'], 'description': "Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.", 'armGroupLabels': ['Chinese herb & acupuncture', 'Chinese herb & sham acupuncture', 'Placebo & acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Guang'anmen Hospital, China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ran Pang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang'anmen hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The agreement for sharing IPD is not designed to be signed in informed consent form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ran Pang', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}