NCT05493124

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2021

Typical duration for early_phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 9, 2022

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

July 29, 2022

Last Update Submit

August 5, 2022

Conditions

Chronic Atrophic Gastritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

  • 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

Study Arms (3)

Manpixiao treatment group

EXPERIMENTAL

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

Blank treatment group

NO INTERVENTION

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

Interventions

ManpixiaoDRUG

A traditional Chinese medicine composition

Manpixiao treatment group
Active comparatorDRUG

Other drugs that may have therapeutic effects

Active comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dongfang Hospital, Beijing University of Chinese Medicine

Beijing, China

RECRUITING

Dongzhimen Hospital, Beijing University of TCM

Beijing, China

RECRUITING

Zaozhuang Hospital, Beijing University of Chinese Medicine

Beijing, China

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 9, 2022

Study Start

July 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 9, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Obtained by asking the first or correspondent author if necessary

Shared Documents
CSR
Time Frame
One year after the completion of the study
Access Criteria
Obtained by asking the first or correspondent author if necessary

Locations

CN(3)