Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shanghai University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT00920712

First received: June 11, 2009

Last updated: August 20, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2009

Last Updated Date

August 20, 2009

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00920712 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Indicates of liver and renal function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

Official Title ^ICMJE

Not Provided

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Gastritis

Intervention ^ICMJE

Drug: Weiqi decotion

Decoction ,two times a day

Study Arm (s)

Experimental: Weiqi decoction
Intervention: Drug: Weiqi decotion
Placebo Comparator: low dose of Weiqi decoction
Intervention: Drug: Weiqi decotion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

July 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of Chronic Atrophic Gastritis
Male of female patients between 18-65 years old
Written informed consent

Exclusion Criteria:

Combine with malignant pathology on epithelial dysplasia of gastric mucosa
Combine with duodenal ulcer or gastric ulcer
Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
Pregnancy or breast feeding women, or unwilling to have contraception.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00920712

Other Study ID Numbers ^ICMJE

SHTCM-001

Has Data Monitoring Committee

Yes

Responsible Party

Institute of Spleen and Stomach's diseases, Shanghai University of Traditional Chinese Medicine

Study Sponsor ^ICMJE

Shanghai University of Traditional Chinese Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Xie Jianqun, Phd

Shanghai University of Chinese Medicine

Information Provided By

Shanghai University of Traditional Chinese Medicine

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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