Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00920712
First received: June 11, 2009
Last updated: April 18, 2016
Last verified: August 2009
  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 ]

Enrollment: 200
Study Start Date: August 2009
Study Completion Date: July 2012
Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 11, 2009
Last Updated: April 18, 2016
Health Authority: China: 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 August 25, 2016