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

NCT07648394 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2026-KY-178-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intestinal Flora; Anorectal Diseases; Surgery; Constipation

Outcome Measures

Primary Outcomes (1)

• Change in Patient Assessment of Constipation-Symptoms Total Score From Baseline to Day 14

  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.

  From baseline before treatment to the end of treatment on Day 14.

Study Arms (2)

Shouhui Tongbian Capsules Treatment Group

EXPERIMENTAL

Drug: Shouhui Tongbian Capsules

Lactulose Oral Solution Control Group

ACTIVE COMPARATOR

Drug: Lactulose Oral Solution Control Group

Interventions

Lactulose Oral Solution Control Group DRUG

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.

Lactulose Oral Solution Control Group

Shouhui Tongbian Capsules DRUG

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.

Shouhui Tongbian Capsules Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Chaoyang District, 100029, China

Location

MeSH Terms

Conditions

Rectal Diseases; Constipation

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lihua Zheng

CONTACT

13366566578; Zhenglihua0819@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)