NCT00948870

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 7, 2013

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

July 28, 2009

Last Update Submit

March 6, 2013

Conditions

Irritable Bowel SyndromeTraditional Chinese Medicine

Keywords

alternative medicine

Outcome Measures

Primary Outcomes (1)

  • Symptoms and conditions of tongue and pulse

    4 weeks

Secondary Outcomes (1)

  • Indicates of liver and renal function

    4 weeks

Study Arms (2)

Shugan Decoction

EXPERIMENTAL
Drug: Shugan decoction

low does of Shugan decoction

PLACEBO COMPARATOR
Drug: Shugan decoction

Interventions

Shugan decoctionDRUG

Decoction ,two times a day,one bag of decoction one time

Shugan Decoctionlow does of Shugan decoction

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of irritable bowel syndrome（diarrhea type）
  • Male of female patients between 18-65 years old
  • Written informed consent

You may not qualify if:

  • Discrepancy of irritable bowel syndrome
  • Diarrhea-type of irritable bowel syndrome combine with intestinal disease
  • Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
  • Pregnancy or breast feeding women, or unwilling to have contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

shugan liangxue

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Xie Jianqun, Phd

    Shanghai University of Chinese Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

March 7, 2013

Record last verified: 2009-08

Locations

CN(1)