An open labelled randomized controlled clinical study to evaluate the anti-hyperglycemic activity of novel ayurvedic choorna in the management of prameha vis-a-vis type2 diabetes mellitus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fasting Plasma Glucose Level
研究概览
简要总结
This study is randomized, open, parallel group, single centred trial comparing the safety and efficacy of Novel Ayurvedic choorna 12 gm daily in study group comparing with Nishamalaki choorna 12 gm daily in positive control group for 3 months in 20 each patients with Type 2 Diabetes Mellitus, that will be conducted in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka. The primary outcome measures will be estimation of Fasting Glucose Level, Two-hour plasma Glucose level and HbA1c. The secondary outcome measures will be clinical symptoms of Diabetes Mellitus (Pratyatmaka lakshanas of Prameha) and WHO Qualitry of life assessment.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of all gender and age group between 30-60 years will be included.
- •Subjects with FBS greater than or equal to 126mg/dl and or PPBS greater than or equal to 200mg/dl will be included.
- •Subjects with HbA1c greater than or equal to 6.5% Diagnosed cases of Type2 Diabetes Mellitus.
- •Subjects with and without signs and symptoms of Prameha vis-a-vis Type2 Diabetes Mellitus will be included.
排除标准
- •Subjects with history of Diabetes Mellitus associated with complications like diabetic nephropathy, retinopathy, neuropathy, infectious wounds and gangrene will be excluded.
- •Patients with known systemic disorders like; cardiac illness, renal pathologies, other endocrinal diseases, uncontrolled hypertension, infectious conditions and debilitating illness which interfere with intervention will be excluded.
- •Patients of Type 2 Diabetes Mellitus who are on OHA and Insulin treatment will be excluded.
- •Subjects on any other medications, drug and alcohol abuse, Steroids and Estrogen replacement therapy will be excluded.
- •Pregnant and the lactating women will be excluded.
结局指标
主要结局
Fasting Plasma Glucose Level
时间窗: 3 month
Two-hour Plasma Glucose Level
时间窗: 3 month
HbA1c
时间窗: 3 month
次要结局
- Clinical symptoms of Diabetes Mellitus.(WHO-QOL.)