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Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

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ClinicalTrials.gov Identifier: NCT00920712
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Gastritis Drug: Weiqi decotion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2009
Primary Completion Date : June 2012
Study Completion Date : July 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Indicates of liver and renal function [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920712


Locations
China, Shanghai
Longhua hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: Xie Jianqun, Phd Shanghai University of Chinese Medicine
More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00920712     History of Changes
Other Study ID Numbers: SHTCM-001
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: August 2009

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