To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
Xiyuan Hospital
Beijing, Beijing Municipality, China
Wangjing Hospital
Beijing, Beijing Municipality, China
Dongzhimen Hospital
Beijing, Beijing Municipality, China
Longhua Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Score less than 75 points was considered as in remission, 75\~175 as mild, 175\~300 as moderate, and over 300 as severe.
Time frame: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Serum markers regarding liver and kidney function
Time frame: at baseline and 8 weeks.
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