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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 because the information has not been verified recently.
Verified October 2010 by Hunan University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01232114
First received: October 19, 2010
Last updated: November 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with functional dyspepsia primary care clinic were studied

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232114

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

Locations
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
Investigators
Study Director: Liu b yan, doctor Hunan university of TCM
  More Information

No publications provided

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
Study First Received: October 19, 2010
Last Updated: November 1, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013