Prospective observational cohort study on the efficacy and safety of Evodia Radix Recipe in the treatment of chronic non-atrophic gastritis

Not Applicable

• Conditions: Chronic non-atrophic gastritis

• Registration Number: ITMCTR2200006408
• Lead Sponsor: Fifth Medical Center of PLA General Hospital

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

? Age 18 to 65 years old, male or female;
? Western medicine diagnosed as chronic non-atrophic gastritis;
? TCM syndrome differentiation is the liver-fire invading stomach syndrome or liver-stomach deficiency-cold syndrome;
? Subjects of childbearing age who voluntarily take effective contraceptive measures during the trial;
? Voluntarily signed the informed consent.

Exclusion Criteria

? Gastroscopy with esophageal disease, peptic ulcer, tumor, bleeding lesions;
? Combined with severe dysplasia of gastric mucosa and pathological diagnosis of suspected malignant transformation;
? Patients with autoimmune gastritis were excluded by serum gastrin, vitamin B12 levels and related autoantibodies (anti-parietal cell antibodies and anti-intrinsic factor antibodies);
? Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumors, AIDS or coagulation disorders;
? Laboratory examination: Scr>N (N is the upper limit of normal value); ALT, AST>N; white blood cells <3.0×109/L;
? Allergic constitution, such as those who are allergic to drugs or food; or those who are known to be allergic to research drugs;
? Patients with alcoholism and drug dependence, with a history of epilepsy or with mental disorders;
? Pregnant, lactating women or those planning to become pregnant;
? Those who have participated in or are participating in other clinical trials within 3 months;
? Other patients deemed unsuitable for the study by the investigator.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Clinical observational indicators;Liver damage indicators;Kidney damage indicators;Nerve damage evaluation index;

Secondary Outcome Measures

Name	Time	Method
Histopathological findings;TCM syndrome score;Endogenous metabolites;Clinical efficacy indicators;Gastroscopy results;