Not Yet RecruitingPhase 1/2

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

China120 participantsStarted 2026-08-01

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Constipation Symptom Score from Baseline to Week 8

Timeframe: Baseline and Week 8

Trial details

NCT IDNCT07648394

SponsorChina-Japan Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Lihua Zheng

13366566578 Zhenglihua0819@163.com

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