Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Value of eGFR
研究概览
简要总结
The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness.
Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria.
This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety.
The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Participants' age is between 20 to 80 years.
- •Participants CKD stage are from 2 to 4(eGFR from 89 to 15)
- •Participants under regular western medicine therapy.
- •Participants who agree to follow the trial protocol.
- •Participants who can complete the study treatment and assessments.
排除标准
- •Participants who are already under hemodialysis, Peritoneal Dialysis or kidney transplant.
- •Participants who are participating in other clinical trials.
- •Participants with hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer.
- •Women who are pregnant.
研究组 & 干预措施
Pu Yang Wan Wu Tang plus Pentoxifylline
干预措施: Pu Yang Wan Wu Tang plus Pentoxifylline (Drug)
Pentoxifylline
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Value of eGFR
时间窗: At 12-weeks
次要结局
- Value of Creatinine(At 12-weeks)
- Ratio of Urine Protein/Urine Creatinine(At 12-weeks)
- Value of GOT(At 12-weeks)
- Value of BUN(At 12-weeks)
- Value of GPT(At 12-weeks)
研究者
Su, Po-Hsuan
Principal Investigator
Taipei Medical University Hospital