Efficacy of gugguluthikthaka taila and jaloukavacharana in lower extremity peripheral arterial disease associated with type 2 diabetes mellitus: A Randomized controlled clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in 6 – minutes walking distance (6MWD)
研究概览
简要总结
This study is a randomized, parallel group single centre trial comparing the efficacy of Gugguluthikthaka taila 15ml bid daily for 60 days combined with Jaloukavacharana ( Medicinal leech therapy) 7times at 7days interval in intervention arm and Jaloukavacharana (Medicinal leech therapy) 7times at 7days interval in control arm in 64 patients with Lower extremity peripheral arterial disease associated with type 2 diabetes mellitus, that will be conducted in single centre, at Government Ayurveda College Hospital,Tripunithura, Ernakulam,Kerala,India. This study is a part of PhD clinical research. The primary outcome measure will be 6- minutes walking distance(6MWD) assessed on 0th, 45th and 61st days of study period. The secondary outcomes will be Rutherford clinical classification of PAD assessed on 0th, 45th and 61st days , Colour doppler study of arterial system of lower extremity will de done before and after study and Total Cholesterol, LDL, HDL, Triglycerides, ESR, Serum Creatinine, Hb, FBS,PPBS and HbA1C on 0th and 61st days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •LE-PAD in known T2DM patients diagnosed by clinical examination and colour Doppler study of lower limb arteries.
- •IC due to unilateral or bilateral PAD (Rutherford 1-3) or Rutherford category 0 with atherosclerotic plaques in either femoropopliteal or below popliteal arteries in arterial Doppler study.
- •Age group 40-75 years
- •Atherosclerosis of femoropopliteal and below popliteal arteries in colour Doppler study.
- •Informed written consent.
排除标准
- •Advanced PAD beyond IC (rest pain, ulcer, gangrene, Rutherford 4-6)
- •Prior revascularization in lower extremities in previous 12 months.
- •Neurogenic/venous/orthopedic claudication more dominant than arterial.
- •Acute PAD
- •Buerger’s disease
- •Contra indication of snehana
- •Cardiac failure
- •Uncontrolled hypertension.
结局指标
主要结局
Change in 6 – minutes walking distance (6MWD)
时间窗: Measurement of 6 – minutes walking distance (6MWD) - 0th, 45th and 61st days of study period.
次要结局
- 1.Rutherford clinical classification of PAD(2. Colour doppler study of arterial system of affected lower extremities)
研究者
Dr Deepa Jose
Government Ayurveda College, Tripunithura