OPEN LABEL SINGLE ARM CLINICAL STUDY ON EFFICACY OF NIMBAPHALA VATI (Azadirachta indica Juss) AS MADHUMEHAHARA (ANTIDIABETIC ACTIVITY) IN TYPE II DIABETES MELLITUS.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This synopsis proposes an open-label, single-arm clinical study to evaluate the antidiabetic (Madhumehahara) effect of Nimba Phala Vati prepared from Azadirachta indica (neem fruit) in patients with type 2 diabetes mellitus aged 30–60 years. Thirty patients with FBS > 126 mg/dL and PPBS > 200 mg/dL will receive Nimba Phala Vati 1 g/day in two divided doses before food for 30 days, and changes in Madhumeha symptoms plus FBS, PPBS, FUS and PPUS between day 0 and day 31 will be assessed. PPBS, FUS and PPUS between day 0 and day 31 will be assessed.The protocol includes pharmacognostic and analytical standardization of Nimba Phala and the Vati, predefined inclusion/exclusion criteria, ADR monitoring and reporting via Ayush Suraksha, allowance for rescue and concomitant medications, and statistical
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects above 30 years up to 60 years of either gender suffering from Type 2 Diabetes Mellitus will be taken.
- •Fasting Blood Sugar MORE THAN OR EQUAL TO 126 mg/dL.
- •Post Prandial Blood Sugar MORE THAN OR EQUAL TO 200 mg/dL.
- •Those patients willing to participate in the study and who are ready to sign the informed consent form.
排除标准
- •Subjects with Type 2 Diabetes Mellitus who are on insulin.
- •Subjects With Diabetic complications like Diagnosed Diabetic foot, Diagnosed Diabetic Retinopathy, Diagnosed Diabetic Neuropathy, Diagnosed Diabetic Nephropathy and other secondary complications.
- •Patients with impaired Cardiac, Hepatic and Renal Functions.
- •Pregnant and Lactating woman.
研究者
DR MOUNESHWAR P PATTAR
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan