Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Irritable Bowel Syndrome With Diarrhea

Treatments

Drug: Chang'an I Recipe

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02822118

Digestion-03

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.