protocolSection identificationModule nctId: NCT06319729, orgStudyIdInfo id: REC/22-23/0659, briefTitle: A Chinese Herbal Medicine for IBS-C, acronym: CDD2105RCT1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hong Kong Baptist University, class: OTHER, descriptionModule briefSummary: This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up., conditionsModule conditions: Constipation-predominant Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A double-blind, placebo-controlled randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All the study drugs and placebo should be in the same package with the same drug appearance and blinded according to the randomized numbers of the subgroups. The specific blinding method is set as follows: the study drugs and placebo are uniformly packaged and numbered according to the corresponding randomized group results. One copy of the blinding letter in duplicate is sent with the test drug to the project leader of the test center for storage, and the other copy is kept by the pharmacy until the end of the trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: CDD-2105, interventions name: Placebo, outcomesModule primaryOutcomes measure: Abdominal Pain Responder Rate, primaryOutcomes measure: Complete Spontaneous Bowel Movement (CSBM) Responder Rate, secondaryOutcomes measure: Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10), secondaryOutcomes measure: Change in the number of days of abdominal pain per week, secondaryOutcomes measure: Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency, secondaryOutcomes measure: Change in the average weekly Spontaneous Bowel Movement (SBM) frequency, secondaryOutcomes measure: Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire, secondaryOutcomes measure: Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM), secondaryOutcomes measure: Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire, secondaryOutcomes measure: Safety: number of adverse events, secondaryOutcomes measure: Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False