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
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lihua Zheng
- Phone Number: 13366566578
- Email: Zhenglihua0819@163.com
Study Locations
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Chaoyang District
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Beijing, Chaoyang District, China, 100029
- China-Japan Friendship Hospital
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Contact:
- Lihua Zheng
- Phone Number: 13366566578
- Email: Zhenglihua0819@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Surgical indication for a benign anorectal disease, including hemorrhoids or anal fistula Diagnosis of postoperative constipation after benign anorectal surgery Postoperative constipation symptoms such as difficulty defecating, reduced bowel movement frequency, hard or lumpy stools, incomplete evacuation, anorectal obstruction, or abdominal distension Ability to tolerate the planned anorectal surgical procedure without related contraindications Consciousness and ability to cooperate with treatment, follow-up, and questionnaire assessments Written informed consent provided by the participant or legally authorized representative Age 18 to 75 years, inclusive
Exclusion Criteria:
Severe systemic disease, including serious psychiatric or immune disorders Severe infection Malignant tumor Severe organic disease of a major organ, including the heart, liver, or kidneys Pregnancy Breastfeeding Postpartum period Coagulation dysfunction Other anorectal disease that may affect outcome assessment Known allergy to either study treatment or any treatment component Any other condition considered by the investigators to make participation unsuitable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Shouhui Tongbian Capsules Treatment Group
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Participants assigned to the Shouhui Tongbian Capsule group will receive routine postoperative care together with oral Shouhui Tongbian Capsule for 14 consecutive days.
The dose will be two capsules per administration, three times daily, taken with warm water approximately 30 minutes after breakfast, lunch, and dinner.
Each capsule contains 0.35 g of the approved marketed product.
During the treatment period, other laxatives, probiotics, Chinese herbal medicines, or drugs that may affect intestinal motility or gut microbiota will generally be prohibited unless clinically necessary.
Medication use, treatment adherence, drug dispensing, returns, adverse events, and any rescue treatment will be recorded throughout the study.
|
|
Active Comparator: Lactulose Oral Solution Control Group
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Participants assigned to the lactulose group will receive routine postoperative care together with lactulose oral solution for 14 consecutive days.
Lactulose will be administered orally at a dose of 15 mL once daily in the morning.
Participants will receive both verbal and written instructions on the dose, administration method, and treatment schedule.
During the study, other laxatives, probiotics, Chinese herbal medicines, or medications that may affect intestinal motility or gut microbiota will generally be prohibited unless clinically necessary.
Treatment adherence, concomitant medications, adverse events, and any rescue treatment for severe constipation, pain, or postoperative discomfort will be recorded in the case report form.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Assessment of Constipation-Symptoms Total Score From Baseline to Day 14
Time Frame: From baseline before treatment to the end of treatment on Day 14.
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The Patient Assessment of Constipation-Symptoms questionnaire is a 12-item participant-reported measure used to assess the severity of constipation symptoms.
The questionnaire includes four abdominal symptom items, three rectal symptom items, and five stool symptom items.
Each item is rated on a 5-point scale from 0 to 4, where 0 indicates "absent," 1 indicates "mild," 2 indicates "moderate," 3 indicates "severe," and 4 indicates "very severe."
The overall score is calculated as the mean of the completed item scores and ranges from 0 to 4. Higher scores indicate more severe constipation symptoms.
The questionnaire will be completed before treatment and on Day 14. Change from baseline will be calculated as the Day 14 score minus the baseline score; a larger negative change indicates greater improvement.
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From baseline before treatment to the end of treatment on Day 14.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-KY-178-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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