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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

N-of-1 trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FLCWK

FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months

Group Type EXPERIMENTAL