A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total intradialytic hypotension (IDH) epidose
研究概览
简要总结
To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM
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
- Double (Participant, Investigator)
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
- •Maintenance bicarbonate hemodialysis (HD) for more than 1 year, three times a week 3.5 to 4.5 h HD schedule.
- •Have experienced more than 30% episodes of IDH (defined as a systolic BP<90 mmHg on dialysis or requirement for clinical intervention) during the exposure assessment period (months 1-3) of this study
- •Cognitive ability to give written informed consent.
排除标准
- •Allergic history to Chinese herbal medicine
- •Systemic diseases such as coagulation disorders, malignancy, liver diseases and cardiovascular diseases.
- •Estimated survival time < 1 year.
- •Mental illness.
- •Participate in other clinical trials.
研究组 & 干预措施
CHM intervention group
干预措施: CHM intervention group (Drug)
Control group
Participants who do not receive the active CHM treatment during the study's initial phase (8 weeks) but are offered it after the trial ends.
干预措施: No CHM treatment (Other)
结局指标
主要结局
Total intradialytic hypotension (IDH) epidose
时间窗: week 1 to 8
IDH episode was record on every dialysis session, account for 24 dialysis sessions. ( IDH was defined as a nadir SBP of \< 90 mmHg or requirement for clinical intervention).
次要结局
- Intradialytic blood pressure (BP) measurement(week 1 to 8)
- Pharmacotherapy(week 1 to 8)
- Kidney Disease and Quality of Life-36 (KDQOL-36)(week 1 and 8)
研究者
Ming-Yen Tsai
Head of Chinese medicine
Chang Gung Memorial Hospital