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

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Drug: Chang'an I Recipe; Drug: Placebo

• Registration Number: NCT02822118
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chang'an I Recipe	Chang'an I Recipe	Patients in this group were administered the Chang'an I Recipe for 8 weeks.
Placebo	Placebo	Patients in this group were administered the placebo for 8 weeks.

Primary Outcome Measures

Name	Time	Method
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)	IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.	Score less than 75 points was considered as in remission, 75\~175 as mild, 175\~300 as moderate, and over 300 as severe.

Secondary Outcome Measures

Name	Time	Method
Serum markers regarding liver and kidney function	at baseline and 8 weeks.

Trial Locations

Locations (5)

Zhejiang Provincial Hospital of TCM; 🇨🇳 Hangzhou, Zhejiang, China

Wangjing Hospital; 🇨🇳 Beijing, Beijing, China

Xiyuan Hospital; 🇨🇳 Beijing, Beijing, China

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China

Longhua Hospital; 🇨🇳 Shanghai, Shanghai, China