NCT06324825招募中不适用
Fuzhegn Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Recovery rate of Low-grade Intraepithelial Neoplasia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fuzhegn Nizeng Formula
Experimental
干预措施: Fuzhegn Nizeng Decoction (Drug)
Moluodan patient medicine
Active Comparator
干预措施: Moluodan granules (Drug)
结局指标
主要结局
Recovery rate of Low-grade Intraepithelial Neoplasia
时间窗: The 180 days after drug administration.
Stomach biopsy will be taken after drug administration completion.
次要结局
- Adverse event rate(The 6 months during the drug administration)
- 7-point Global Overall Symptom Scale(1st, 2nd, 3rd, 4th, 5th, 6th month)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Clinical study on Fuzheng Tongluo Formula in the treatment of idiopathic pulmonary fibrosisIdiopathic pulmonary fibrosisITMCTR2000003803Shuguang Hospital Affiliated to Shanghai University of TCM
已完成
不适用
Treatment of chronic fatigue syndrome by a Chinese herbal formula Sijunzi decoctioISRCTN23930966onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine127
招募中
1 期
A clinical research for Fuzheng Sanjie Recipe in the treatment of ground glass nodule of lungGround glass nodule of lungITMCTR2000003849Shuguang Hospital affiliated with Shanghai University of TCM
尚未招募
1 期
Mechanism and Clinical research of Zhenganxifeng dispensing granule decoction for treatment of hypertension with Yin Deficiency and Yang Hyperactivity Syndrome based on network pharmacologyEssential hypertensionITMCTR2000003146Affiliated Hospital of Shandong University of TCM
尚未招募
1 期
Clinical Study of Guijiangxiancha Formula on Overweight/Obesity Patients with Yang Deficiency of Spleen and KidneyOverweight/ObesityITMCTR2023000002Xiyuan Hospital of China Academy of Chinese Medical Sciences