Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Atrophic Gastritis
• Intervention / Treatment: Drug: Manpixiao; Drug: Active comparator

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Dongfang Hospital, Beijing University of Chinese Medicine
    • Contact: Xia Ding; Phone Number: 13611184842; Email: dingx@bucm.edu.cn
  • Beijing, China
    • Recruiting
    • Dongzhimen Hospital, Beijing University of TCM
    • Contact: Xia Ding; Phone Number: 13611184842; Email: dingx@bucm.edu.cn
  • Beijing, China
    • Recruiting
    • Zaozhuang Hospital, Beijing University of Chinese Medicine
    • Contact: Xia Ding; Phone Number: 13611184842; Email: dingx@bucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manpixiao treatment group; 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	Drug: Manpixiao; A traditional Chinese medicine composition
NO_INTERVENTION: Blank treatment group
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.	Drug: Active comparator; Other drugs that may have therapeutic effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological improvement rate of gastric mucosa	Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric mucosal status under gastroscope	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.	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.
Score of main symptoms of stomach system	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.	They were evaluated on the day of enrollment and the day of the end of the treatment process

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (ACTUAL): August 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Gastritis; Atrophy; Gastritis, Atrophic
• Other Study ID Numbers: 2021-ZXFZJJ-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Obtained by asking the first or correspondent author if necessary
• IPD Sharing Time Frame: One year after the completion of the study
• IPD Sharing Access Criteria: Obtained by asking the first or correspondent author if necessary
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No