Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Beijing University of Chinese Medicine

Status and phase: Unknown; Early Phase 1

Conditions: Chronic Atrophic Gastritis

Treatments: Drug: Manpixiao; Drug: Active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT05493124

2021-ZXFZJJ-035

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Manpixiao treatment group

Experimental group

Description:

A traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks

Treatment:

Drug: Manpixiao

Blank treatment group

No Intervention group

Active comparator

Active Comparator group

Description:

Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions.

Treatment:

Drug: Active comparator