RecruitingNot ApplicableNCT06324825

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

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


Sponsor

Peking University First Hospital

Enrollment

144 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

Interventions

DRUGFuzhegn Nizeng Decoction

Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month.

DRUGMoluodan granules

Subjects taking prepared Moluodan granules 9g twice daily for 6 month.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06324825