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

Peking University

Status: Enrolling

Conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia

Treatments: Drug: Fuzhegn Nizeng Decoction; Drug: Moluodan granules

Study type: Interventional

Funder types: Other

Identifiers

NCT06324825

2022CR64

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Fuzhegn Nizeng Formula

Experimental group

Treatment:

Drug: Fuzhegn Nizeng Decoction

Moluodan patient medicine

Active Comparator group

Treatment:

Drug: Moluodan granules