Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Early Phase 1

• Conditions: Chronic Atrophic Gastritis
• Interventions: Drug: Manpixiao; Drug: Active comparator

• Registration Number: NCT05493124
• Lead Sponsor: Beijing University of Chinese Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manpixiao treatment group	Manpixiao	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
Active comparator	Active comparator	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.

Primary Outcome Measures

Name	Time	Method
Pathological improvement rate of gastric mucosa	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.	Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy

Secondary Outcome Measures

Name	Time	Method
Score of main symptoms of stomach system	They were evaluated on the day of enrollment and the day of the end of the treatment process	Adopt the "table of main symptoms of stomach system based on doctor's report", the specific contents are: epigastric (epigastric) pain, epigastric (epigastric) distension, epigastric (epigastric) blockage, heartburn, acid reflux, belching, anorexia, reduced appetite. Score 0, 1, 2 and 3 points for the severity of each single symptom (none, mild, moderate and severe). The total score of symptoms is the sum of the individual scores. By comparing the changes of individual symptom scores and total symptom scores between groups, lower scores mean better results.
Gastric mucosal status under gastroscope	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.	For the color of gastric mucosa, spots, erosion, bleeding, reduced folds, visible blood vessels and mucosal texture, 0, 1, 2 and 3 points are given according to the levels of none, I, II and III respectively, and 0 and 1 points are given according to the presence or absence of bile reflux. According to the gastroscopy report, score the patients' microscopic results before and after treatment, and take the result change as the secondary index of curative effect. A lower score means a better result.

Trial Locations

Locations (3)

Dongfang Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China

Zaozhuang Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China

Dongzhimen Hospital, Beijing University of TCM; 🇨🇳 Beijing, China