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

First Received on June 11, 2009. Last Updated on August 20, 2009 History of Changes

Sponsor:	Shanghai University of Traditional Chinese Medicine
Information provided by:	Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00920712

Purpose

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

Condition	Intervention
Gastritis	Drug: Weiqi decotion

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

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	August 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Weiqi decoction	Drug: Weiqi decotion Decoction ,two times a day
Placebo Comparator: low dose of Weiqi decoction	Drug: Weiqi decotion Decoction ,two times a day

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920712

Locations

China, Shanghai
Longhua hospital	Recruiting
Shanghai, Shanghai, China, 200032
Contact: zheng Peiyong, Phd 86-21-64286261 pan_youjun@126.com

Sponsors and Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

Study Director:

Xie Jianqun, Phd

Shanghai University of Chinese Medicine

More Information

No publications provided

Responsible Party:	Institute of Spleen and Stomach's diseases, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00920712 History of Changes
Other Study ID Numbers:	SHTCM-001
Study First Received:	June 11, 2009
Last Updated:	August 20, 2009
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:

chronic atrophic gastritis
Traditional Chinese Medicine

Additional relevant MeSH terms:

Gastritis
Gastritis, Atrophic
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on February 09, 2012