CTRI/2021/06/034030尚未招募不适用
A preclinical and clinical study to determine the efficacy of Neelkanthi Churna in management of Madhumeha w.s.r to Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Principal
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fulfillment of objective and subjective criteria
研究概览
简要总结
I would like to publish my research trial after completion of the trial as soon as possible. Patients will selected from OPD & IPD of R.G.G.P.G Ayurvedic College & Hospital Paprola.
3 groups of 30 patients will be registered then assessed to evaluate the efficacy of Neelkanthi Churana in Madhumeha w.s.r Diabetes Mellitus Type 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 20-70yrs.
- •Newly diagnosed patients of Type 2 Diabetes Mellitus having glycosylated Hb (HbA1C) between 6.5% to 10% 3) Patients willing to participate in the trial.
排除标准
- •Subject of Type-1 DM or Type-2 DM on insulin/OHA’s other than Metformin/ any other medication for glucose control in the last 3 months Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc.
- •which require an urgent treatment.
- •Patients having major medical illness like cancer, concurrent infection like tuberculosis.
- •Patients with uncontrolled Hypertension.
- •Patients with established diagnosis of CAD or any other clinically significant cardiovascular disease.
- •Renal dysfunction (defined by eGFR< 60ml/min calculated by MDRD calculator) Subjects who have completed participation in any other clinical trial during the past 3 months.
- •Any other condition which the investigator thinks may compromise the safety of subject.
- •Subjects with Haemoglobin percentage < 9gm% for males and < 8gm%for females.
结局指标
主要结局
Fulfillment of objective and subjective criteria
时间窗: 12 weeks
次要结局
- Efficacy of Neelkanthi Churna in type 2 Diabetes Mellitus(12 weeks)
研究者
研究点 (1)
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