Clinical trial

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

Name
ShouFa-2022-2-4077
Description
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.
Trial arms
Trial start
2022-08-02
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
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.
Arms:
MLD
WFC
Chinese patent medicine, take according to the instructions, the course of treatment is 6 months.
Arms:
WFC
Size
286
Primary endpoint
Therapeutic effectiveness of gastric mucosal lesions
Half a year,a year
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood;Biopsy specimen of gastric mucosa'}, 'enrollmentInfo': {'count': 286, 'type': 'ESTIMATED'}}
Updated at
2023-09-05

1 organization

2 products

1 indication

Product
MLD
Indication
Gastritis
Product
WFC