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

NCT ID: NCT06324825

Condition: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia

Conditions: Official terms:
Neoplasms
Carcinoma in Situ
Gastritis
Gastritis, Atrophic
Atrophy

Conditions: Keywords:
Atrophic Gastritis
Intraepithelial Neoplasia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Fuzhegn Nizeng Decoction
Description: Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month.
Arm group label: Fuzhegn Nizeng Formula

Intervention type: Drug
Intervention name: Moluodan granules
Description: Subjects taking prepared Moluodan granules 9g twice daily for 6 month.
Arm group label: Moluodan patient medicine

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Status: Recruiting

Contact:
Last name: Xuezhi Zhang, Doctor

Phone: +861083572634
Email: zhang.xuezhi@263.net

Start date: October 24, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06324825

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