Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-01 @ 11:04 PM
Study NCT ID:
NCT02822118
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)', 'timeFrame': 'IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.', 'description': 'Score less than 75 points was considered as in remission, 75\\~175 as mild, 175\\~300 as moderate, and over 300 as severe.'}], 'secondaryOutcomes': [{'measure': 'Serum markers regarding liver and kidney function', 'timeFrame': 'at baseline and 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["IBS-D; Chang'an I Recipe; Placebo"], 'conditions': ['Irritable Bowel Syndrome With Diarrhea']}, 'descriptionModule': {'briefSummary': "To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients meeting the diagnostic criteria of Western medicine for IBS-D;\n* aged 18-70 years old; with a baseline IBS-SSS score over 75 points;\n* voluntarily signed the informed consent;\n* local resident who could ensure follow-ups, with basic reading ability.\n\nExclusion Criteria:\n\n* Patients with IBS-C, -M, and uncertain forms;\n* accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;\n* gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);\n* undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);\n* with history of abdominal surgery (e.g., cholecystectomy);\n* with an allergy history of tested drugs or severe allergy history of food;\n* pregnant and lactating female;\n* with a history of neurological or psychiatric disorders;\n* or participating in other clinical trial.'}, 'identificationModule': {'nctId': 'NCT02822118', 'briefTitle': "Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea", 'organization': {'class': 'OTHER', 'fullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}, 'officialTitle': "Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial", 'orgStudyIdInfo': {'id': 'Digestion-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Chang'an I Recipe", 'description': "Patients in this group were administered the Chang'an I Recipe for 8 weeks.", 'interventionNames': ["Drug: Chang'an I Recipe"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this group were administered the placebo for 8 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': "Chang'an I Recipe", 'type': 'DRUG', 'otherNames': ['The treatment group'], 'description': "Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.", 'armGroupLabels': ["Chang'an I Recipe"]}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['The control group'], 'description': 'Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xiyuan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100102', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Wangjing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Dongzhimen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Longhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Provincial Hospital of TCM', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'xudong Tang, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'XiYuan Hospital of China Academy of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}