Clinical trial NCT05388890: Treatment of Atrophic Gastritis After HP Eradication With Modified Liujunzi Decoction Based on Syndrome Differentiation
Official title: Clinical Study on the Efficacy of Modified Liujunzi Prescription on the Treatment of Atrophic Gastritis After HP Eradication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Atrophic Gastritis
Keywords: Chronic Atrophic Gastritis
Modified Liujunzi Decoction
Treatment Based on Syndrome Differentiation
Clinical Study
Efficacy
Cohort Study
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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.

Primary outcomes:
measure: Therapeutic effectiveness of gastric mucosal lesions
timeFrame: Half a year,a year
Secondary outcomes:
measure: The efficacy of OLGA,OLGIM
timeFrame: Half a year,a year
measure: Changes in clinical symptom scores
timeFrame: The third month,half a year ,the ninth month,a year.
measure: The recurrence of HP
timeFrame: Half a year,a year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: