NCT05517993尚未招募2 期
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intradialytic hypotension episode
研究概览
简要总结
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease treated with hemodialysis for ≥3 months
- •Receive a standard thrice-weekly hemodialysis schedule
- •More than 25% of hemodialysis sessions complicated by intradialytic hypotension
排除标准
- •Active malignancy
- •Life-threatening conditions
- •Pregnancy
- •Recent participation in another clinical trial for intradialytic hypotension
- •History of hypersensitivity or contraindication to herbal medicine
研究组 & 干预措施
Group A
Experimental
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.
干预措施: Gui-Lu-Er-Xian-Jiao-Wan (Drug)
结局指标
主要结局
Intradialytic hypotension episode
时间窗: Each time of dialysis during 12-weeks study period.
Hypotension episode during hemodialysis
次要结局
- Early termination of hemodialysis(Each time of dialysis during 12-weeks study period.)
- SF-36(Baseline, 12 weeks, 28 weeks)
研究者
研究点 (1)
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