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Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

Primary Purpose

Gastritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Weiqi decotion
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis focused on measuring chronic atrophic gastritis, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Longhua hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Weiqi decoction

low dose of Weiqi decoction

Arm Description

Outcomes

Primary Outcome Measures

Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change

Secondary Outcome Measures

Indicates of liver and renal function

Full Information

First Posted
June 11, 2009
Last Updated
April 18, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00920712
Brief Title
Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis
Keywords
chronic atrophic gastritis, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weiqi decoction
Arm Type
Experimental
Arm Title
low dose of Weiqi decoction
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Weiqi decotion
Intervention Description
Decoction ,two times a day
Primary Outcome Measure Information:
Title
Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Indicates of liver and renal function
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xie Jianqun, Phd
Organizational Affiliation
Shanghai University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Longhua hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

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