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

Chronic Atrophic Gastritis Clinical Trial

Official title:

Clinical Study on the Efficacy of Modified Liujunzi Prescription on the Treatment of Atrophic Gastritis After HP Eradication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388890
• Other study ID #: ShouFa-2022-2-4077
• Status: Recruiting
• Start date: August 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Peking University First Hospital
• Contact: Qiuyue Huang, doctor
• Phone: +86010 83572351
• Email: 1711210349[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Chronic Atrophic Gastritis
• Gastritis
• Gastritis, Atrophic

Intervention

Drug:
• MLD
Modified Liujunzi Decoction is provided by the chinese pharmacy of Peking University First Hospital , one dose per day, taken in twice, and the course of treatment is 6 months.
• WFC
Chinese patent medicine, take according to the instructions, the course of treatment is 6 months.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effectiveness of gastric mucosal lesions	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 .	Half a year,a year
Secondary	The efficacy of OLGA,OLGIM	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%	Half a year,a year
Secondary	Changes in clinical symptom scores	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 third month,half a year ,the ninth month,a year.
Secondary	The recurrence of HP	13C-UBT was performed to determine HP, and the DOB value more than 4 is defined as the recurrence of HP.	Half a year,a year