To hear about similar clinical trials, please enter your email below
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
