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

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chang'an I Recipe
Placebo
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring IBS-D; Chang'an I Recipe; Placebo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiyuan Hospital
  • Wangjing Hospital
  • Dongzhimen Hospital
  • Longhua Hospital
  • Zhejiang Provincial Hospital of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chang'an I Recipe

Placebo

Arm Description

Patients in this group were administered the Chang'an I Recipe for 8 weeks.

Patients in this group were administered the placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum markers regarding liver and kidney function

Full Information

First Posted
June 27, 2016
Last Updated
September 2, 2016
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02822118
Brief Title
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea
Official Title
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
IBS-D; Chang'an I Recipe; Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chang'an I Recipe
Arm Type
Experimental
Arm Description
Patients in this group were administered the Chang'an I Recipe for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this group were administered the placebo for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Chang'an I Recipe
Other Intervention Name(s)
The treatment group
Intervention Description
Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
The control group
Intervention Description
Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
Primary Outcome Measure Information:
Title
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Description
Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe.
Time Frame
IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Secondary Outcome Measure Information:
Title
Serum markers regarding liver and kidney function
Time Frame
at baseline and 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xudong Tang, Ph.D
Organizational Affiliation
XiYuan Hospital of China Academy of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Xiyuan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Name
Wangjing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100102
Country
China
Facility Name
Dongzhimen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhejiang Provincial Hospital of TCM
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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