NCT02822118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

September 5, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

June 27, 2016

Last Update Submit

September 2, 2016

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS-D; Chang'an I Recipe; Placebo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Serum markers regarding liver and kidney function

    at baseline and 8 weeks.

Study Arms (2)

Chang'an I Recipe

EXPERIMENTAL

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

Drug: Chang'an I Recipe

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Chang'an I RecipeDRUG

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

Also known as: The treatment group
Chang'an I Recipe
PlaceboDRUG

Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.

Also known as: The control group
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Xiyuan Hospital

Beijing, Beijing Municipality, 100091, China

Location

Wangjing Hospital

Beijing, Beijing Municipality, 100102, China

Location

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Zhejiang Provincial Hospital of TCM

Hangzhou, Zhejiang, 310006, China

Location

Study Officials

  • xudong Tang, Ph.D

    XiYuan Hospital of China Academy of Traditional Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 4, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

CN(5)