Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a traditional Chinese medicine called Fengliao Changweikang (FLCWK) can help people with a type of irritable bowel syndrome (IBS) that mainly causes diarrhea and belly pain. IBS can be tough to manage with usual treatments, so this study wants to see if FLCWK can improve symptoms and overall quality of life in adults who have mild to moderate IBS with diarrhea.

People eligible to join are between 18 and 75 years old and have been diagnosed with mild to moderate IBS-D, meaning their symptoms are not too mild or too severe. They should be able to fill out questionnaires and have stable treatment routines for their IBS without plans to change their medications or lifestyle during the study. The study involves several treatment periods where participants will take either FLCWK or a placebo (a harmless pill with no active medicine) without knowing which one they’re taking. Each treatment phase lasts four weeks, with breaks in between. This “blind” setup helps researchers fairly compare how well the medicine works. The trial is not yet recruiting, but if you qualify, you can expect a careful and closely monitored process designed to find out if this herbal treatment is safe and helpful.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 75 years.
• • 2. Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points\[14\].
• • 3. Ability to complete questionnaires and provide written informed consent.
• • 4. Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
• • 5. Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.
• Exclusion Criteria:
• • 1. History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
• • 2. Scores of IBS-SSS \> 300 points or IBS-SSS \< 75 points.
• • 3. History of severe heart, kidney or liver diseases.
• • 4. Pregnant or breastfeeding.
• • 5. Current alcohol or drug abuse.