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Research on the Efficacy and Mechanism of Shouhui Tongbian Capsules in Treating Postoperative Constipation of Benign Anal and Rectal Diseases Based on Gut Microbiota Analysis

StatusNot Yet Recruiting
PhasePhase 1/2
Started2026-08-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from China-Japan Friendship Hospital

Amendment history

2026-07-21
Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Primary endpoint(s) modified1 entry, revised
WasChange in Constipation Symptom Score from Baseline to Week 8
NowChange in Patient Assessment of Constipation-Symptoms Total Score From Baseline to Day 14
Eligibility criteria-226 characters
Inclusion Criteria: Surgical Age between 18 and 75 years old, male or female. Undergoing surgeryindication for a benign anorectal diseases (e.g.disease, mixedincluding hemorrhoids, or anal fistula, analDiagnosis fissure). Meeting the diagnostic criteria forof postoperative constipation (e.g.after benign anorectal surgery Postoperative constipation symptoms such as difficulty defecating, fewer than 3 spontaneousreduced bowel movementsmovement perfrequency, weekhard or lumpy stools, incomplete evacuation, anorectal obstruction, or difficultyabdominal indistension defecation). AbleAbility to unde [...] [...]
2026-06-10
Original filing
The goal of this clinical trial is to evaluate whether Shouhui Tongbian Capsule can improve postoperative constipation in adults aged 18 to 75 years after surgery for benign anorectal diseases, including hemorrhoids and anal fistula. The clinical trial will also evaluate the safety of Shouhui Tongbian Capsule and explore associations between treatment effects and changes in gut microbiota, metabolic profiles, and inflammatory indicators. The main questions are: Does Shouhui Tongbian Capsule improve constipation symptoms after benign anorectal surgery? Does Shouhui Tongbian Capsule reduce postoperative and defecation-related pain? Does Shouhui Tongbian Capsule improve quality of life and anorectal function? What adverse events occur during treatment? Are clinical improvements associated with changes in gut microbiota, metabolic profiles, or inflammatory indicators? Researchers will compare Shouhui Tongbian Capsule with lactulose to evaluate differences in efficacy and safety for postoperative constipation. Participants will: Receive either Shouhui Tongbian Capsule three times daily or lactulose once daily for 14 days Complete assessments of constipation symptoms, pain, quality of life, and anorectal function Provide stool and blood samples before treatment and on Day 14 Attend assessments during treatment and approximately 1 month after surgery Report adverse events and other medical problems during participation
Trial Details
NCT Number NCT07648394
Lead Sponsor China-Japan Friendship Hospital
Conditions Intestinal Flora, Anorectal Diseases, Surgery, Constipation
Enrollment 120 participants
Start Date 2026-08-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22