Effect of Integrated Naturopathy and Yoga Intervention to prevent renal complications in Diabetes Mellitus - A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Estimated GFR
研究概览
简要总结
EEven though renal function decline is considered relentless in chronic kidney disease (CKD), improvement has been shown in patients with hypertensive nephropathy, but improvers were not prevalent in diabetic nephropathy. This gives us a solid reason to form an evidence based Naturopathy and Yoga protocol specifically for prevention of diabetic kidney disease using appropriate screening and early markers to identify these patients and treat them prophylactically.
a****Grouping – After screening, subjects will be randomized into intervention and control group using computer generated randomization sheet
Group 1: n = 30
Group 2: n = 30
Group 1: 10 days of in-patient intervention followed by 3 months of tele-intervention, monitoring and follow up
Group 2: Under conventional management
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age range of 30-65 years
- •Long duration of Diabetes mellitus since diagnosis (T2DM since 8-10 years)
- •Patients with moderate to poor glycaemic control (defined as HbA1c greater than 8%)
- •Patients having diabetic dermopathy (diagnosed on clinical examination, defined as non-blanching, scaly, round or oval, red or purple macule or papules of size 1 to 2.5 cm , associated with hyperpigmentation, seen on front of leg).
- •Patients having eGFR either less than 60 mL/kg/1.73m2 (mildly decreased) OR eGFR more than or equal to 125mL/kg/1.73m2(elevated)
- •Diabetics with modifiable risk factors such as smoking, obesity, dyslipidaemia i.e., at risk of developing nephropathy
- •Diabetic patients who are also hypertensive.
排除标准
- •Patients with overt proteinuria greater than 300mg/day
- •Patients having CKD Stage 3B-5, indicated as high risk for CKD progression or renal replacement therapy.
- •Presence of dyselectrolytemia
- •Patients with poorly healed diabetic wound
- •Newly diagnosed low risk DM patients with good glycemic control
- •Pregnant and lactating women (including those with Gestational Diabetes Mellitus).
结局指标
主要结局
1. Estimated GFR
时间窗: Baseline, 10th day post intervention, 3 months follow up post intervention
2. Urinary Microalbumin / Urine Albumin-Creatinine Ratio
时间窗: Baseline, 10th day post intervention, 3 months follow up post intervention
次要结局
- UK Prospective Diabetes Study (UKPDS) Cardiac Risk Engine Score Version 2 - includes Age, Duration of Diabetes, Glycosylated Haemoglobin, Lipid profile, Smoking history, ethnicity, presence/ absence of atrial fibrillation(Baseline, 10th day post intervention, 3 months follow up post intervention)
研究者
Dr Aditi Giridharan
SDM College of Naturopathy and Yogic Sciences