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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.