Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 主要终点
- Methylation index
研究概览
简要总结
The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation.
Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment group
干预措施: Yisui granule (Drug)
control group
干预措施: Placebo (Drug)
结局指标
主要结局
Methylation index
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Wang Jing
associate professor
Dongzhimen Hospital, Beijing
