An Open Labelled Parallel Comparative Clinical Study to evaluate the efficacy of Vangashilajatu and Nishaamalaki in the management of Madhumeha with special reference to Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Vangashilajatu in comparison to Nishaamlaki by applying appropriate statistical tools in the management of Madhumeha
研究概览
简要总结
Diabetes Mellitus has become one of the most alarming health problems of this world because of its devastating consequences. With largest number of Diabetic patients,India has been termed as "The Diabetic capital of the worldâ€. Madhumeha is a type of Vataj Prameha and is also final stage of all Pramehas if left untreated. The Patient passes large quantity of urine which is Kashaya, Madhura, Pandu & Ruksha. Madhumeha shows close resemblance of characteristic features to T2DM. DM is a metabolic disorder and is characterized by increase in blood glucose level, deficiency of insulin or resistance to insulin. So a study will be conducted with the aim to compare the efficacy of Vangashilajatu & Nishaamalaki in the management of Madhumeha for which 60 patients will be randomly selected and divided into 2 groups. In group A (30 patients) 1 cap Vangashilajatu will be given twice 15 min before meal with water and In group B (30 patients) 3 g Nishaamalaki powder will be given 15 min before meal with water for 28 days. Patients will be we regularly followed up at interval of 7 days during treatment & 2 follow ups will be scheduled at interval of 14 days after treatment. Clinical features & laboratory investigation will be analysed during & after the treatment. Results will be analysed in accordance with the appropriate statistical tests.
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing for clinical trials and ready to give written consent.
- •2.Patients with age between 25-60 years of either sex.
- •3.Patients possessing signs and symptoms of Prameha (Diabetes Mellitus).
- •4.Freshly diagnosed & confirmed cases of Madhumeha on the basis of Diagnostic criteria for diabetes.
- •5.FBS-126-200 mg/dl and PPBS-200-300 mg/dl 6.
排除标准
- •Patients not willing for the clinical trail.
- •Patients not fulfilling the inclusion criteria
- •Patients below the age of 25 years and above the age of 60 years.
- •Fasting blood sugar level less than 126mg/dl and greater than 200 mg/dl, post prandial blood sugar level less than 200mg/dl and greater than 300 mg/dl, HbA1C less than 6.5 percentage and greater than 8 percentage
- •Insulin dependent Diabetes mellitus(IDDM), gestational Diabetes, MODY, LADA.
- •Endocrinopathies.
- •Pregnant ladies and lactating mothers.
结局指标
主要结局
To assess the efficacy of Vangashilajatu in comparison to Nishaamlaki by applying appropriate statistical tools in the management of Madhumeha
时间窗: 28 days
次要结局
- 1- Reduction in scoring pattern of sign and symptoms of Madhumeha(2- Improvement and management of blood sugar level and other hematological parameters)
研究者
Dr Himani Bhardwaj
Institute for Ayurved Studies and Research