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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Drug: Chang'an I Recipe
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Serum markers regarding liver and kidney function |  | at baseline and 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS-D; Chang'an I Recipe; Placebo