Clinical trial NCT05493124: Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
Official title: Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Atrophic Gastritis
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.


Eligibility criteria: Inclusion Criteria:

* The age is 18-75 years old, regardless of gender;
* Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
* Sign the informed consent form.

Exclusion Criteria:

* Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
* Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
* Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
* Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
* Patients with chronic liver and kidney dysfunction before treatment, including ALT \> 1.5 times the upper limit of normal value, blood creatinine (CR) \> 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
* Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities);
* The description of self symptoms is unclear or the investigation is not the author;
* Have a history of alcohol abuse;
* Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug);
* Pregnant or lactating women;
* According to the judgment of the researcher, other reasons should not be selected.

Primary outcomes:
measure: Pathological improvement rate of gastric mucosa
timeFrame: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Secondary outcomes:
measure: Gastric mucosal status under gastroscope
timeFrame: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
measure: Score of main symptoms of stomach system
timeFrame: They were evaluated on the day of enrollment and the day of the end of the treatment process
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital, Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of TCM
city: Beijing
country: China
facility: Zaozhuang Hospital, Beijing University of Chinese Medicine
Study officials:
References: