Effect and Safety of Elian Granules for the Treatment of Chronic Atrophic Gastritis: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Not Applicable

• Conditions: Chronic Atrophic Gastritis

• Registration Number: ITMCTR2000003929
• Lead Sponsor: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged 18-70 years, male or female;
(2) Those who meet the diagnostic criteria of chronic atrophic gastritis and the test for Helicobacter pylori is negative. (13C or 14C urea breath test is required);
(3) The pathological stage is OLGA-II/III. Two experts from the Department of Pathology are required for diagnosis (Pathological film reading), whose pathological conclusion should reach an agreement;
(4) Voluntarily participating in this clinical trial and signing informed consent.

Exclusion Criteria

(1) Patients with peptic ulcer, severe dysplasia of the gastric mucosa or pathological diagnosis suspected of malignant transformation;
(2) Those who have severe digestive system diseases or used to have abdominal surgery;
(3) Pregnant or lactating women;
(4) In patients with severe heart and lung diseases , malignant tumor, severe DM and chronic liver and kidney dysfunction, ALT and AST of liver function damage were more than 1.5 times of the upper limit of normal, and renal function damage (BUN > 1.2 times of the upper limit of normal, Cr > the upper limit of normal);
(5) PLT < 1.5 times of the lower limit of normal;
(6) Disabled patients (blind, deaf, dumb, mental disorder, mental disorder, physical disability) as prescribed by law;
(7) Alcoholics;
(8) Those who are known to be allergic to two or more types of drugs or the ingredients of the drug and have allergic constitution;
(9) Patients who participated in other clinical trials within 4 weeks. Patients who have taken Wifuchun, Moluodan and folic acid in within 2 weeks;
(10) In the opinion of the investigator, those who will cause loss to follow-up, or not suitable for inclusion.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastroscopy and Gastric mucosal biopcy;

Secondary Outcome Measures

Name	Time	Method
Indigestion symptom checklist;12-item short-form health survey, SF-12;