CTRI/2022/09/046025尚未招募不适用
A clinical study to evaluate the effect of Pramehhara Kwatha in the management of Madhumeha w.s.r. to Type II 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
- To evaluate the efficacy of an Ayurvedic formulation Pramehhara Kwatha independently and also as add on therapy to Metformin for glycemic control in management of Madhumeha.
研究概览
简要总结
I would like to publish my trial after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College & Hospital Paprola.
A sample of 30 diabetic patients will be registered. Patients will be divided randomly into three groups. Patients will be assessed to evaluate the effect of Pramehhara Kwatha in the management of Madhumeha w.s.r to Type II Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
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 type 2 diabetes mellitus having a. Fasting Plasma Glucose -126 to 200 mg/dl b. PPBS(2-hour Plasma Glucose Level) – 200 to 400 mg/dl c. HbA1C between.
排除标准
- •Subjects suffering from the complications of diabetes mellitus i.e. 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.
- •Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) Uncontrolled acute pulmonary dysfunction requiring inhalational or systemic steroids.
- •Pregnant/ lactating women.
- •Subjects on systemic or oral steroids, oral contraceptives pills or estrogen replacement therapy.
结局指标
主要结局
To evaluate the efficacy of an Ayurvedic formulation Pramehhara Kwatha independently and also as add on therapy to Metformin for glycemic control in management of Madhumeha.
时间窗: Patient will be assessed after 2 weeks, 4 weeks, 8 weeks and at the end of trial (i.e 12 weeks).
次要结局
- To assess the clinical safety of Pramehhara Kwatha in management of Madhumeha w.s.r. to Type II Diabetes Mellitus.
研究者
研究点 (1)
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