Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia
• Interventions: Drug: Moluodan granules; Drug: Fuzhegn Nizeng Decoction

• Registration Number: NCT06324825
• Lead Sponsor: Peking University First Hospital

Brief Summary

Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-24
• Study First Submitted: 2023-09-01
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia diagnosed by endoscopy and stomach biopsy.
• Helicobacter pylori negative.
• TCM syndrome is spleen-stomach deficiency with blood stasis and phelgm.

Exclusion Criteria

• History of gastric surgery.
• Combined with malignant tumor.
• History of mental illness.
• Allergy to any components of the drug use in the study.
• Planning to pregnancy, or pregnant woman and lactating woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moluodan patient medicine	Moluodan granules	-
Fuzhegn Nizeng Formula	Fuzhegn Nizeng Decoction	-

Primary Outcome Measures

Name	Time	Method
Recovery rate of Low-grade Intraepithelial Neoplasia	The 180 days after drug administration.	Stomach biopsy will be taken after drug administration completion.

Secondary Outcome Measures

Name	Time	Method
7-point Global Overall Symptom Scale	1st, 2nd, 3rd, 4th, 5th, 6th month	Dyspepsia symptoms will be recorded and evaluated by 7-point Global Overall Symptom Scale
Adverse event rate	The 6 months during the drug administration	Any adverse event will be recorded.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China