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

NCT ID: NCT01232114

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hunan University of Traditional Chinese Medicine

Principal Investigators

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Liu b yan, doctor

Role: STUDY_DIRECTOR

Hunan university of TCM

Locations

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Hunan university of TCM

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cai g xian, Master

Role: CONTACT

Phone: 8673188458001

Email: [email protected]

Facility Contacts

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Yi jian, master

Role: primary

Other Identifiers

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CB523002

Identifier Type: -

Identifier Source: org_study_id