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

Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Drug: Chang'an I Recipe; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Dongzhimen Hospital
    • Beijing, Beijing, China, 100091
      • Xiyuan Hospital
    • Beijing, Beijing, China, 100102
      • Wangjing Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Zhejiang Provincial Hospital of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chang'an I Recipe; Patients in this group were administered the Chang'an I Recipe for 8 weeks.	Drug: Chang'an I Recipe; Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.; Other Names: The treatment group
Placebo Comparator: Placebo; Patients in this group were administered the placebo for 8 weeks.	Drug: Placebo; Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.; Other Names: The control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum markers regarding liver and kidney function	at baseline and 8 weeks.

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: xudong Tang, Ph.D, XiYuan Hospital of China Academy of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: IBS-D; Chang'an I Recipe; Placebo
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: Digestion-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES