Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia (SMT)

November 1, 2010 updated by: Hunan University of Traditional Chinese Medicine

Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily becoming a public health problem.Simotang is a classical formula that has been used to treat gastrointestinal disorders for hundreds of years [9] and was approved as an oral liquid drug by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with functional dyspepsia were divided according to the inclusive criteria into treatment group and control group randomly, who were given Simo decoction or Domperidone tablets for 14 days。And then the gastric emptying, Symptoms in plasma were observed before and after treatment in mult-center.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan university of TCM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with functional dyspepsia primary care clinic were studied

Description

Inclusion Criteria:

  • patients met the definition of the Rome III criteria for FD

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan University of Traditional Chinese Medicine

Investigators

  • Study Director: Liu b yan, doctor, Hunan university of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB523002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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