Randomized controlled trial of “shaladi churna†as an add-on effect in the Management of madhumeha with special reference to diabetes mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin
研究概览
简要总结
The prevalence of Diabetes Mellitus is rapidly rising through the globe at an alarming rate, where India leads with largest number of diabetics and become Diabetes Capital of the World. Mdhumeha is one of the most common, chronic, aliment. Now a day’s many formulations are described to treat Madhumeha. Among these Shaladi Churna is one of the drug described in Nighanturatnakar. Shaladi Churna having its own properties like Tridoshahar, Agnideepan, Anuloman, Kaphashaman. It possess anti-diabetic effects through their anti-oxidant properties. Shaladi Churna having Medoghna, Mutral properties. The prevalence rate of DM is 14.6. Diabetes is the 6th leading cause of death in India. We have developed newer medicines, but we come across limitations to OHA and Insulin. Hence there is need for Ayurvedic formulations to prevent the complications of DM and to treat the hyperglycemia. Due to sedentary life style people have no time to take Shodhan Chikitsa like Panchakarma. Thus this disease is increases day by day. Considering all above things the study will be carried out in comparison with conventional modern treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age group: between 30 years to 60 years.
- •Gender: Male and Female both will be included.
- •A known Diabetic on treatment and newly diagnosed Diabetes.
- •Patient with fasting blood sugar up to 220 mg/dl & post prandial blood sugar upto 300 mg/dl.
- •Patient having HbA1c in between 7 to 9 and Sr. Insulin.
排除标准
- •IDDM, Acromegaly, Cushing’s syndrome and pancreatic disorder.
- •Pregnant and lactating mothers.
- •Patients with K/C/O Nephropathy, Neuropathy and Retinopathy.
- •Patients with gastrointestinal diseases, Liver diseases, tumours, cardio vascular disease, acute myocardial infarction, immune-compromised disease(HIV).
结局指标
主要结局
Glycosylated hemoglobin
时间窗: at baseline, 4 weeks, 8 weeks and 12 weeks
Blood Sugar levels
时间窗: at baseline, 4 weeks, 8 weeks and 12 weeks
次要结局
未报告次要终点