A randomized, open-label, parallel-controlled clinical study on the efficacy and safety of Shouhuitongbian Capsule combined with Shouhuitongbian Probiotics in the treatment of functional constipation (qi and yin deficiency syndrome)

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2024
INTERVENTION: Treatment group 2:Phase 1 14±2 days: Shouhui Laxative Capsules; Phase 2 42±4 days: First Companion Probiotics.;Treatment group 1:The first stage is 14±2 days: Shouhui Laxative Capsule + Shouhui Mate Probiotic; Phase 2 42±4 days: First Companion Probiotics.;Treatment group 3:Phase 1 14±2 days: Shouhui Laxative Capsules; Phase 2: None; CONDITION: Functional constipation (qi and yin deficiency syndrome) PRIMARY OUTCOME: Number of complete spontaneous bowel movements (CSBM) response rate:Proportion of patients who meet; SECONDARY OUTCOME: The number of bowel movements (BM) in the last week of the treatment period compared to baseline;Constipation Quality of Life Assessment Scale (PAC‐QOL);Stool Condition (Using the Bristol Stool Character Scale) score compared to baseline in the last wee;TCM Syndrome Points;Mean weekly stool trait score;Occurrence of completely spontaneous bowel movement (CSBM) within 24 hours of starting treatment;Changes in intestinal flora;Proportion of subjects with an average of 3 complete spontaneous bowel movements (CSBM=) per week wi;Remediation of drug use;The average number of SBMs per week;The number of spontaneous bowel movements (SBM) in the last week of the treatment period compared to; INCLUSION CRITERIA: 1: Age 18 70 years old (including boundary value), gender is not limited 2: Meets Western medical diagnostic criteria for functional constipation 3: The syndrome differentiation in traditional Chinese medicine is the deficiency pattern of qi and yin 4: Voluntarily participate in this trial and sign a written informed consent document
Epistemonikos ID: 002ba7e01628f3ad9ead80502e9cfd865639c4be
First added on: Aug 28, 2024