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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01232114
Recruitment Status : Unknown
Verified October 2010 by Hunan University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Functional Dyspepsia(FD) Was Studied Effect of Simotang on FD Was Studied

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
Study Start Date : October 2010
Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with functional dyspepsia primary care clinic were studied

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232114

Contact: Cai g xian, Master 8673188458001 lby1203@sina.com

China, Hunan
Hunan university of TCM Recruiting
Changsha, Hunan, China, 410007
Contact: Yi jian, master    8673185381065    yijian556@126.com   
Sponsors and Collaborators
Hunan University of Traditional Chinese Medicine
Study Director: Liu b yan, doctor Hunan university of TCM
More Information

Responsible Party: Key Lab. for Chinese Internal Medicine, Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01232114     History of Changes
Other Study ID Numbers: CB523002
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases