Randomised Standard control clinical trial to evaluate an adjuvant effect of Triphala Darvyadi Ghan Vati in Madhumeha Upadrava with special referance to Diabetic Nephropathy.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evaluate the Effect of Triphala Darvyadi Ghan Vati as an Adjuvant with Standard of Care in Diabetic Nephropathy through RFT GFR, Urine Routine & Microscopic, ACR Ratio
研究概览
简要总结
Accordingto epidemiological studies, there is increasing number of Diabeticcomplications. The prevalence of overt Diabetic Nephropathy is 2.2% in urbanAsian Indians. Madhumeha compared to Diabetes Mellitus because of havingsimilarities of disease respect to clinical features & etiopathogenesis. Acharyahad keen observation which gave the base to Madhumeha Upadravas mentioned inayurvedic text which can be corelated modern concept of complications of DiabetesMellitus. Diabetic Nephropathy is leading cause of chronic kidney disease,being responsible for 30-40% of all End Stage Renal Disease cases.
So, there isneed of Ayurvedic Medicine to prevent & to reduce the progression of thecomplications of Diabetes like Nephropathy. To establish Ayuevedic kalpas, inthe Diabetic Nephropathy this study is undertaken i.e. Randomized controlledclinical trial to evaluate adjuvant effect of Triphala Darvyadi Ghana vati in Madhumehaupdravas with special reference to Diabetic Nephropathy. The present study iscarried out to study the efficacy of ayurvedic herbel compound TriphalaDarvyadi Ghan Vati with application of modern parameters which are –
ObjectiveParameters - RFT, ACR ratio, GFR, HbA1c, BSL, Urine Routine.
SubjectiveParameters – Avilamutrata, Naktamutrata, Pipasavrudhi, Padshotha, Dourbalya,Akshikuta shotha.
There are 2 groupsin study. Triphala Darvyadi Ghan Vati with Standard of care to trial group andonly Standard of care to Control group for 3 months duration. Follow up – 1st,45th, 90th Day. Conclusion will be drawn on the basis ofstastical analysis at the final stage of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •1.Signs & symptoms of Madhumeha (According to Charakacharya).
- •2.Signs & Symptoms of Madhumeha Upadrava related to Diabetic Nephropathy.
- •3.Known case of Non-Insulin Dependent Diabetes Mellitus (Type 2 DM).
- •4.Patients having HbA1c up to
- •6.Patients with fasting blood sugar upto 250 mg/dl & postprandial blood sugar upto 350 mg/dl.
- •5.Patients taking oral hypoglycemic agents since 6 months.
- •6.Patients having Serum Creatinine level normal to 2.5 mg/dl.
排除标准
- •1.Patients with acute complications like hypoglycemic coma, ketoacidosis and related complications, history of complications, infections like gangrene.
- •2.Patients with known chronic diabetic complications such as end stage renal disease, patients receiving dialysis, cardiac complications, neuropathy.
- •3.Pregnant and lactating women.
- •4.Patients suffering from all major systemic diseases, IHD, TB, HIV, Carcinoma, uncontrolled HTN.
结局指标
主要结局
Evaluate the Effect of Triphala Darvyadi Ghan Vati as an Adjuvant with Standard of Care in Diabetic Nephropathy through RFT GFR, Urine Routine & Microscopic, ACR Ratio
时间窗: 1st, 45th, 90th Day
次要结局
- Observe the Effect of Triphala Darvyadi Ghan Vati in BSL & HbA1c(1st, 45th, 90th Day)