Treatment of Atrophic Gastritis After HP Eradication With Modified Liujunzi Decoction Based on Syndrome Differentiation

Recruiting

• Conditions: Chronic Atrophic Gastritis
• Interventions: Drug: MLD; Drug: WFC

• Registration Number: NCT05388890
• Lead Sponsor: Peking University First Hospital

Brief Summary

This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation group and Weifuchun routine treatment as the control group, so as to provide evidence for the treatment of CAG and reduce the risk of gastric cancer. A total of 284 patients were included. The curative efficacy, symptom score and adverse events will be recorded and analyzed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-08-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Patients with CAG diagnosed by endoscopy and pathological examination, the pathological diagnosis criteria refer to the China consensus of chronic gastritis (2017) ;
• Previous HP infection, HP negative after standardized treatment;
• TCM syndrome differentiation mainly focuses on the weakness of the spleen and stomach,referring to the consensus on the diagnosis and treatment of chronic atrophic gastritis with integrated traditional Chinese and Western Medicine (2017), there is no restriction on concurrent syndrome;
• Age 18-70 years old, regardless of gender;
• The subject (or legal representative) voluntarily agreed and signed the informed consent form, and was able to abide by the study protocol during the study.

Exclusion Criteria

• History of gastric surgery;
• Combined with serious diseases affecting the study evaluation, such as serious liver disease, heart disease, kidney disease, malignant tumor and alcoholism;
• Allergic to the drugs used in this study;
• Participated in clinical research of other drugs in the first 3 months of the study;
• Patients can't express correctly their subjective feelings and can't cooperate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MLD	MLD	Modified Liujunzi Decoction,1 package twice daily,6 months
WFC	WFC	Weifuchun,three times a day, four at a time,6months

Primary Outcome Measures

Name	Time	Method
Therapeutic effectiveness of gastric mucosal lesions	Half a year,a year	Referring to the CAG of the "Guidelines for Clinical Research on New Chinese Medicines (2002)", the effective treatment of gastric mucosal lesions is defined as "the pathological score decreased by 1 point compared with the previous point". The effective rate of gastric mucosal lesions treatment = the number of cases with a decrease of ≥ 1 point by the previous score / the total number of cases × 100%. The effective rate of gastric mucosal lesions from different category will be calculated: respectively for atrophy, chronic inflammation, activity, intestinal metaplasia, and intraepithelial neoplasia .

Secondary Outcome Measures

Name	Time	Method
The recurrence of HP	Half a year,a year	13C-UBT was performed to determine HP, and the DOB value more than 4 is defined as the recurrence of HP.
Changes in clinical symptom scores	The third month,half a year ,the ninth month,a year.	Evaluate referring to the symptom grading and quantification standard of "Guidelines for Clinical Research on Chronic Atrophic Gastritis" from "Guidelines for Clinical Research on New Chinese Medicines (2002)".According to the clinical symptom severity assign different points. No, mild, moderate and severe symptoms are recorded as 0, 1, 2, and 3 point respectively. Record the changes of the symptom score at 6 months and 12 months compared with the baseline and evaluate . The calculation formula is " the total score after treatment-the score in baseline ".
The efficacy of OLGA,OLGIM	Half a year,a year	The efficacy of OLGA staging: OLGA staging decreased by ≥1 stage compared with the baseline is considered as effecacy.The effective rate = the number of cases with ≥1 stage decreased compared with the previous stage/the total number of cases × 100%.; The efficacy of OLGIM staging:The OLGIM staging decreased by ≥1 stage from the baseline is considered effective for patients with intestinal metaplasia. The effective rate = the number of cases staging decreased by ≥ 1 stage compared with the previous stage /the total number of cases × 100%

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China