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

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

Brief Summary

Study Title A study to learn how Shouhui Tongbian Capsules works to relieve constipation after anorectal surgery, and explore its effects linked to gut bacteria. Why we do this study Constipation is a common problem after surgery for hemorrhoids, anal fistula and other benign anorectal diseases. It causes pain, slows wound healing and lowers quality of life. Traditional laxatives may lead to stomach pain, electrolyte problems and drug dependence. Shouhui Tongbian Capsules is a traditional Chinese herbal medicine. It can ease constipation and protect the intestinal tract at the same time. This research aims to check how well this medicine works for post-surgery constipation, whether it reduces pain, and find out its working mechanism related to gut microbiota. We also want to collect evidence for better combined traditional Chinese and Western medicine treatment in clinic. Who can take part Adults aged 18 to 75 who receive surgery for benign anorectal diseases and have constipation Fully aware of the study and willing to sign an informed consent form People with severe organ diseases, mental illness, cancer, bleeding disorders, pregnancy or other conditions will not be included. How the study works This is a prospective, randomized, controlled clinical trial. A total of 120 patients will be randomly divided into two groups (60 people each): Test group: Take Shouhui Tongbian Capsules, 2 pills three times a day for 8 weeks. Control group: Take lactulose oral solution, the common medicine for constipation. We will assess symptoms regularly before, during and after treatment. We will record constipation severity, traditional Chinese medicine symptom scores, pain scores (VAS), quality of life (SF-36), physical signs and blood test results. We will also test gut bacteria and inflammation levels to analyze the medicine's mechanism. Safety All participants will be closely monitored throughout the study. We will record any discomfort or side effects in a timely manner to ensure safety. Expected benefits This study will confirm the effectiveness and safety of Shouhui Tongbian Capsules for post-anorectal surgery constipation. It may help relieve your constipation and post-operative pain, speed up recovery and improve daily life. The results will also help doctors choose better treatments for similar patients in the future. Study timeline May - June 2026: Complete ethical review and study preparation July - September 2026: Recruit participants and start treatment Late 2026 - Early 2027: Finish data collection, analysis and paper writing

Conditions

Intestinal Flora; Anorectal Diseases; Surgery; Constipation

Outcome Measures

Primary Outcomes (1)

• Change in Constipation Symptom Score from Baseline to Week 8

  Baseline and Week 8

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

Oral administration of Lactulose Oral Solution (15 mL once daily) combined with routine postoperative care for 8 consecutive weeks. This is a common osmotic laxative used to treat postoperative constipation in patients with benign anorectal diseases.

Lactulose Oral Solution Control Group

Shouhui Tongbian Capsules DRUG

Intervention DescriptionOral administration of Shouhui Tongbian Capsules (2 capsules, three times daily) combined with routine postoperative care for 8 consecutive weeks. This patented Chinese herbal formula is designed to improve bowel function and relieve constipation in patients after benign anorectal surgery.

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:

• Meeting the diagnostic criteria for postoperative constipation (e.g., fewer than 3 spontaneous bowel movements per week, or difficulty in defecation).
• Able to understand the study procedures and voluntarily sign the informed consent form.
• Able to cooperate with medication administration, follow-up visits, and data collection.

You may not qualify if:

• History of inflammatory bowel disease, irritable bowel syndrome, or severe chronic constipation unrelated to surgery.
• History of gastrointestinal surgery (other than the planned anorectal surgery) within the past 3 months.
• Pregnancy, breastfeeding, or planned pregnancy during the study period (for female participants).
• Known allergy or contraindication to the study drugs (Shouhui Tongbian Capsules or lactulose).
• Current use of other laxatives, prokinetic drugs, or traditional Chinese medicine for constipation within 1 month before enrollment.
• Severe mental disorders, cognitive impairment, or inability to communicate effectively.
• Participation in other clinical trials within the past 3 months. Any other condition judged by the investigator to make the participant unsuitable for this study.

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 (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

CN (1)