A Phase 4 interventional study of FLCWK and Placebo in Irritable Bowel Syndrome - Diarrhoea, Traditional Chinese Medicine (TCM) and N of 1 Study Design, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
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.
Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
Drug: FLCWK · Drug: Placebo
Placebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
Drug: FLCWK · Drug: Placebo
FLCWK and matching placebo to be taken in a randomised order for 9 months
FLCWK and matching placebo to be taken in a randomised order for 9 months
IBS-SSS score
The severity score questionnaire consists of 5 items and each item is rated on a scale of 0-100 points, leading to a total score of 0-500 points. An improvement of more than 50 points for IBS-SSS questionnaire is considered clinical effective.
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
IBS-QOL score
IBS-QOL is a 34-item questionnaire assessing patient's health related quality of life, and higher scores indicate a better quality of life. IBS-QOL focuses on eight domains, namely dysphoria, activity interference, body image, health worry, food avoidance, social reaction, sexual and relationships, and an increase of more than 14 points indicates clinical improvement in quality of life. The minimal clinically important difference (MCID) on the IBS-QOL is defined as a change of 10 points in the total score.
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
self-reported symptoms including abdominal pain and diarrhea
The score of worst abdominal pain in the past 24 hours will be evaluated by visual analogue scale (VAS) ranging from 0 to 10. The stool consistency of the past 24 hours will also be rated by BSFS, based on a 1 to 7 scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.
Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital