Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

Gastritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920712
• Other study ID #: SHTCM-001
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: April 18, 2016
• Start date: August 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2009
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastritis
• Gastritis, Atrophic

Intervention

Drug:
• Weiqi decotion
Decoction ,two times a day

Locations

Country	Name	City	State
China	Longhua hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change		12 weeks	No
Secondary	Indicates of liver and renal function		12 weeks	Yes