CTRI/2018/01/011497招募中2 期
A Prospective open labelled Randomized Clinical trial on herbal formulation of “Seenthil Sarkkarai†for the treatment of Iyaneerizhivu (Chronic Obstructive pulmonary Disease in patient with Type II Diabetes Mellitus )
Dr S Neelavathi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The therapeutic efficacy of trial drug Seenthil Sarkkarai on IYA NEERIZHIVU
研究概览
简要总结
The Study is prospective open labelled randomized phase II clinical trial to evaluate the therapeutic efficacy of herbal formulation of seenthil sarkkarai for the treatment of IYA NEERIZHIVU 130mg kg BW daily three time per day with ghee for 90 days in 40 patients during the trial period of 12 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic eficacy of trial drug Seenthil Sakkarai on IYA NEERIZHIVU The Secondary outcome will be the evaluation of Siddha diagnositc parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetes mellitus If yes in any of three FBS above 110 mg per dl and below and equal 250mg per dl or PPBS above 160 mg per dl and below and equal 350mg per dl HbA1c above 6.4 and below 10 Persistent cases of COPD as per the standard key indicators for assessment FEV1 between above 50 percentage and below 80 percentage of the predicted value Willing to give blood sample for the investigations Patients who are mono therapy alone.
排除标准
- •Age below 40 and above 70 Type 1 diabetes mellitus If yes in any of three FBS below 109 mg per dl and above and equal 251 mg per dl or PPBS below 159 mg per dl and above and equal 351 mg per dl HbA1c below 6.3 and above 10.1 FEV1 below 50 percentage and above 80 percentage of the predicted value Pregnant woman and plan to pregnant six months Lactating mother Chronic kidney disease or Renal failure Corticosteroid therapy Chronic active hepatitis or cirrhosis or ascites Multisystem involvement.
结局指标
主要结局
The therapeutic efficacy of trial drug Seenthil Sarkkarai on IYA NEERIZHIVU
时间窗: 90 days
次要结局
- Evaluation of Siddha diagnostic parameters(90 days)
研究者
研究点 (1)
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