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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02822118
Other study ID # Digestion-03
Secondary ID
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


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
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