Preclinical and clinical study to evaluate the safety and efficacy of ‘Shreshthadi vati’ in management of ‘Madhumeha’ with special reference to type-2 diabetes mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes in objectives parameter- F.B.S. ,P.P.B.S.from baseline value.
研究概览
简要总结
In India, prevalence of diabetes mellitus is increasing at an alarming rate. Once an individual is diagnosed with diabetes mellitus the dosage of medicine is ever increasing and ultimately insulin has to be given for glycemic control. Despite of recent progression in medical science, several challenges still exist in the management of diabetes that requires special attention to develop un-explored fields of medical knowledge. Ayurveda offers comprehensive safe and effective approaches to manage this through its effect over Dhatu-agni vikriti which is considered as basic factor in the development of Madhumeha (Diabetes Mellitus).
Among the wide varieties of drugs mentioned in Ayurveda text books the selected drug ‘Shreshthadi Vati’ is described as a significantly effective and safe drug in Rastantra Saar Evam SiddhaPrayoga Samgriha in ‘Prameha Prakaran’ but there is no research work done on‘Shreshthadi vati’ till now, so this study will be done to evaluate the effect and safety profile of “Shreshthadi vati†in Madumeha w.s.r.to type-2 diabetes mellitus. The contents of this drug are easily available, cost effective and drug is easy to administer in the patients. That is the basic reason to select this drug for present trial.
Aims and objectives: -The present study has been designed with following aims and objectives.
ï‚— 1)To validate the safety profile (oral acute toxicity) of Shreshthadi Vati in Wistar albino rats.
ï‚— 2)To evaluate the efficacy of Shreshthadi Vati in streptozotocin induced diabetes mellitus in Wistar albino rats.
ï‚— 3)To evaluate the clinical efficacy of Shreshthadi Vati in the management of Madhumeha w.s.r. to type-2 diabetes mellitus.
Hypothesis: -
Null hypothesis(H0): -There is no effect of trial drug ‘Shreshthadi Vati’ in management of Madhumeha with special reference to Type-2 diabetes mellitus
Alternative Hypothesis(H1): - There is significant effect of trial drug ‘Shreshthadi Vati’ in management of Madhumeha with special reference to Type-2 diabetes mellitus
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient ready to give consent for trial and willing to participate in the study.
- •Patient between the age group of 18-70 years.
- •Sex- male and female patient.
- •Newly diagnosed (not more than 2 years) case of Madhumeha (Type 2 diabetes mellitus).
- •Patient with FBS –in range of 126-200mg/dl PPBS-in range of 200-300mg/dl.
排除标准
- •Patient not willing to sign the consent form.
- •Patients having Type-1 Diabetes Mellitus.
- •FBS>200 mg/dl and PPBS>300 mg/dl.
- •Patients of Type-2 diabetes mellitus who are on insulin therapy and Drug induced diabetes mellitus.
- •Type-2 diabetes mellitus with complications and Madhumeha with Ashadhya upadrava.
- •Patients having any serious illness like cardiovascular diseases, renal disease, hepatic disease, malignancy, any other endocrinopathies etc.
- •Pregnant and lactating mother.
结局指标
主要结局
changes in objectives parameter- F.B.S. ,P.P.B.S.from baseline value.
时间窗: 30 days
次要结局
- Changes in the clinical symptoms of Mahdumeha (Type 2 diabetes(mellitus))