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Functional Dyspepsia(FD) Was Studied | Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Functional Dyspepsia(FD) Was Studied research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - patients met the definition of the Rome III criteria for FD Exclusion Criteria:

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia(FD) Was Studied

Effect of Simotang on FD Was Studied

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: October 2010

Completed Date: October 2010

Phase:

Type: Observational

Design:

Primary Outcome: Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety

Secondary Outcome: Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy

Study sponsors, principal investigator, and references

Principal Investigator: Liu b yan, doctor

Lead Sponsor: Hunan University of Traditional Chinese Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01232114

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