An interventional study of Fuzhegn Nizeng Decoction and Moluodan granules in Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 144 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Drug: Fuzhegn Nizeng Decoction
Drug: Moluodan granules
Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month.
Subjects taking prepared Moluodan granules 9g twice daily for 6 month.
Recovery rate of Low-grade Intraepithelial Neoplasia
Stomach biopsy will be taken after drug administration completion.
Time frame: The 180 days after drug administration.
7-point Global Overall Symptom Scale
Dyspepsia symptoms will be recorded and evaluated by 7-point Global Overall Symptom Scale
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th month
Adverse event rate
Any adverse event will be recorded.
Time frame: The 6 months during the drug administration
Plan to share: Undecided
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Peking University First Hospital