Clinical trial NCT02822118: Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea
Official title: Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS-D; Chang'an I Recipe; Placebo
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the diagnostic criteria of Western medicine for IBS-D;
* aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
* voluntarily signed the informed consent;
* local resident who could ensure follow-ups, with basic reading ability.

Exclusion Criteria:

* Patients with IBS-C, -M, and uncertain forms;
* accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
* gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
* undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
* with history of abdominal surgery (e.g., cholecystectomy);
* with an allergy history of tested drugs or severe allergy history of food;
* pregnant and lactating female;
* with a history of neurological or psychiatric disorders;
* or participating in other clinical trial.

Primary outcomes:
measure: change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
timeFrame: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Secondary outcomes:
measure: Serum markers regarding liver and kidney function
timeFrame: at baseline and 8 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital
state: Beijing
city: Beijing
country: China
facility: Wangjing Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
Study officials:
affiliation: XiYuan Hospital of China Academy of Traditional Chinese Medicine
name: xudong Tang, Ph.D
role: STUDY_CHAIR
References: