NCT07061184

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

The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development. This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients. After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.

Conditions

• Irritable Bowel Syndrome - Diarrhoea
• Traditional Chinese Medicine (TCM)
• N of 1 Study Design
• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	FLCWK	FLCWK and matching placebo to be taken in a randomised order for 9 months
DRUG	Placebo	FLCWK and matching placebo to be taken in a randomised order for 9 months

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-11-01
• Completion: 2028-05-01
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: China