A SINGLE ARM OPEN LABEL NON-RANDOMISED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KVGAP’S MEHACARE CAPSULE IN MADHUMEHA (TYPE II DIABETES MELLITUS)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness, Polyneuritis
研究概览
简要总结
An open label non-randomized clinical trial will be conducted with KVGAP’S MEHACARE CAPSULE for a purpose to evaluate its efficacy on Type II Diabetes mellitus with the help of various Ayurvedic physicians. Thirty patients of both sexes between the age group of 30-65 years, who are clinically diagnosed as suffering from Type II Diabetes mellitus and who were willing to give informed consent will be enrolled in the study.
All enrolled patients will undergo a through clinical examination and will be assessed for subjective parameters: Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness and Polyneuritis; Objective parameters: FBS, PPBS & HbA1C. The patients will be advised to take with KVGAP’S MEHACARE CAPSULE daily twice before food for a period of 2 months. Follow up of patients will be conducted at baseline, at the end of 15 days. 30 days, 45 days and at the end of 60 days. Obtained data will be analyzed statistically by relevant statistical test and efficacy is assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Only uncomplicated cases of type-2 DM with FBS more than 126 mg/dl and less than 200 mg/dl.
- •With at least one of the following symptoms: Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness, Polyneuritis.
排除标准
- •Patients presenting with complications like severe renal disease, ischemic heart disease, severe hypertension etc.
- •Patients with type-1 DM 3) Patients outside the age group of 30-65 years.
结局指标
主要结局
Polyphagia, Polydypsia, Polyuria, Nocturnal micturition, Exhaustion/ Fatigue, Bodyache, Giddiness, Polyneuritis
时间窗: Baseline, After 15 days, After 30 Days, After 45 Days, After 60 days
次要结局
未报告次要终点
研究者
Dr Gopalakrishna N Nayak
KVG Ayurveda Medical College and Hospital
