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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822118
• Other study ID #: Digestion-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 27, 2016
• Last updated: September 2, 2016
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• Chang'an I Recipe
Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
• Placebo
Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing
China	Wangjing Hospital	Beijing	Beijing
China	Xiyuan Hospital	Beijing	Beijing
China	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Serum markers regarding liver and kidney function		at baseline and 8 weeks.	Yes