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

June 10, 2026 updated by: Lihua Zheng, China-Japan Friendship Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chaoyang District
      • Beijing, Chaoyang District, China, 100029
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Age between 18 and 75 years old, male or female. Undergoing surgery for benign anorectal diseases (e.g., mixed hemorrhoids, anal fistula, anal fissure).

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.

Exclusion Criteria:Severe organic diseases of the heart, liver, kidney, or other vital organs.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Shouhui Tongbian Capsules Treatment Group
Drug: Shouhui Tongbian Capsules
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.
Active Comparator: Lactulose Oral Solution Control Group
Drug: Lactulose Oral Solution Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Constipation Symptom Score from Baseline to Week 8
Time Frame: Baseline and Week 8
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Constipation

Clinical Trials on Shouhui Tongbian Capsules

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe