An open labelled, Randomised clinical control study to evaluate the effect of Navak Guggul Yog in the management of non-proliferative Diabetic Retinopathy (NPDR)- Preclinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of navak guggul yog in the management of non proliferative Diabetic Retinopathy
研究概览
简要总结
Diabetic mellitus is a major non epidemic metabolic disorder affecting over million people worldwide .the disorder is rapidly increasing out in developing and developed countries , especially type 2 Diabetes Mellitus which is associated with the modern lifestyle habits such as reduced physical activity ,diet ,obesity and genetic factors .
Major complications of DM are heart disease , stroke ,kidney failure,foot ulcers,microvascular ischemic diseases , peripheral artery disease,microvascular neuropathy,nephropathy and retinopathy .
Diabetic Retinopathy is a chronic progressive potentially sight threatening disease.
Existing conventional therapy of treatment of diabetic mellitus is not preventing the development of diabetic Retinopathy .
According to WHO expert committee diabetes mellitus is major cause of avoidable blindness , good glycemic control arrest the development and progression of diabetic Retinopathy and decrease the visual loss .
Who recommended that traditional system of medicine should be encouraged for prevention and treatment of diabetes mellitus complications especially when conventional pharmacotherapy is not full effective .
Hence Navak guggul yog is well known polyherbal formulation for Diabetic Retinopathy and other DM complications.it acts as kaphagna and medoghna and thus can have an additive protective and preventive role in diabetes mellitus .
The aim of present study was to confirm and illustrate the mechanism of protective action of Navak guggul yog in prevention of Diabetic Retinopathy and its complications .
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Sign and symptoms of nonproliferative diabetic Retinopathy. Age
- •60 years . Patient having type 2 DM with hba1c less than 8 . Hypertensive patients having controlled bp less than 140/90mmhg.
排除标准
- •Proliferative Diabetic Retinopathy Uncontrolled Bp & bsl Infective & inflammatory conditions of eye Hiv , cox , Hbs Ag positive Not willing.
结局指标
主要结局
To evaluate the efficacy of navak guggul yog in the management of non proliferative Diabetic Retinopathy
时间窗: 90 days...follow up on every 30 days
次要结局
- 1.To observe the addon effect of Navak guggul yog in micro aneurysm, retinal haemorrhage and hard exudates in NPDR.(2.to study whether navak guggul yog prevent the progression of non proliferative Diabetic Retinopathy to proliferative Diabetic Retinopathy .)