Trial of Chinese Prescription Shugan Decoction on Irritab... | NCT00948870

Studies
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）

NCT00948870

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Mar 7, 2013Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Traditional Chinese Medicine

Interventions

Shugan decoction

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2013

Last Update Posted Date

Mar 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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）.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shugan Decoction	Experimental		Drug: Shugan decoction
low does of Shugan decoction	Placebo Comparator		Drug: Shugan decoction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shugan decoction	Drug	Decoction ,two times a day,one bag of decoction one time	Shugan Decoction low does of Shugan decoction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms and conditions of tongue and pulse		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Indicates of liver and renal function		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xie Jianqun, Phd	Shanghai University of Chinese Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Longhua hospital		Shanghai	Shanghai Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000629000	shugan liangxue

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided