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

NCT05388890 | Unknown

• 1 other identifier: ShouFa-2022-2-4077
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Atrophic Gastritis

Keywords

Chronic Atrophic Gastritis; Modified Liujunzi Decoction; Treatment Based on Syndrome Differentiation; Clinical Study; Efficacy; Cohort Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The efficacy of OLGA,OLGIM

  Half a year,a year

• Changes in clinical symptom scores

  The third month,half a year ,the ninth month,a year.

• The recurrence of HP

  Half a year,a year

Study Arms (2)

MLD

Modified Liujunzi Decoction,1 package twice daily,6 months

Drug: MLD

WFC

Weifuchun,three times a day, four at a time,6months

Drug: WFC

Interventions

MLD DRUG

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.

MLD

WFC DRUG

Chinese patent medicine, take according to the instructions, the course of treatment is 6 months.

WFC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the willingness of the patients, the CAG patients after HP eradication in the routine diagnosis and treatment of the Department of integrated traditional Chinese and Western medicine and the Department of Gastroenterology of the Peking University First Hospital were enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood;Biopsy specimen of gastric mucosa

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

Qiuyue Huang, doctor

CONTACT

+86010 83572351; 1711210349@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: August 2, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

CN (1)