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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Hunan University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
Information provided by:
Hunan University of Traditional Chinese Medicine Identifier:
First received: October 19, 2010
Last updated: November 1, 2010
Last verified: October 2010
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.

Functional Dyspepsia(FD) Was Studied
Effect of Simotang on FD Was Studied

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hunan University of Traditional Chinese Medicine:

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

Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

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
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Please refer to this study by its identifier: NCT01232114

Contact: Cai g xian, Master 8673188458001

China, Hunan
Hunan university of TCM Recruiting
Changsha, Hunan, China, 410007
Contact: Yi jian, master    8673185381065   
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 Identifier: NCT01232114     History of Changes
Other Study ID Numbers: CB523002
Study First Received: October 19, 2010
Last Updated: November 1, 2010

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases processed this record on May 25, 2017