Controlled Evaluation of the Composite Management of Prameha with Samshodhana and Varadi Ghanavati.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Effect on symptoms of Prameha according to four point scale at the interval of 2 weeks till 12 weeks.
研究概览
简要总结
Ayurveda prescribes Shodhana - Panchakarma as the first line of treatment in newly diagnosed obese patients of Prameha (Diabetes Mellitus). Due to the body cleansing effect of Panchakarma it evacuates Dosha responsible for causing Prameha. As it is disease predominantly caused due to Kapha, Vamana is the treatment of choice as first line of treatment. But effect of Vamana in cases of Prameha (Diabetes mellitus) remains largely unexplored.
After Shodhana - Panchakarma treatment, use of medicines is the second line of treatment in Prameha (Diabetes mellitus) as prescribed by Ayurvedic treatises. Varadi Ghanavati is a classical Ayurvedic herbal medicine containing - Vatsaka (Holarrhena antidysentrica wall), Triphala (combination of Amalaki - Emblica officinalis, Haritaki - Terminalia chebula Retz, Bibhitaka - Terminalia bellirica Roxb.), Daruharidra (Berberis aristata), Musta (Cyprus rotundus Linn.), Vijaysara (Pterocarpus marsupium Roxb.). All the ingredients of Varadi Ghanavati are potent Pramehagha. They are also researched for their anti diabetic effects. Hence the study was undertaken to evaluate effect of Shodhana (Vamana) and Varadi Ghanavati in comparison with effect of Varadi Ghanavati without Shodhana (Vamana) treatment and active control treatment with glibenclamide.
The results showed that the group receiving Vamana as well as Varadi Ghanavati showed better control on blood sugar as well as lipid levels. Other two groups receiving Varadi Ghanavati without Shodhana and control group showed good glycemic control but showed no significant change in lipid levels. Hence oral Ayurvedic medication followed by Panchakarma (Vamana) can be better treatment option in treatment of Prameha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients showing classical symptoms of Prameha, who are either a known diabetic for less than a year or a newly diagnosed diabetic.
- •Fasting blood sugar below 250 mg/dl and post prandial blood sugar below 500 mg/dl.
- •Fit for Vamana treatment.
排除标准
- •Fasting blood sugar above 250 mg% and post prandial blood sugar above 500mg%.
- •IDDM and those who are under insulin therapy.
- •Acute or chronic complications of Diabetes mellitus
- •Suffering from other diseases such as Tuberculosis, cardiac diseases.
- •Unfit for Vamana.
结局指标
主要结局
Effect on symptoms of Prameha according to four point scale at the interval of 2 weeks till 12 weeks.
时间窗: Effect on symptoms of Prameha according to four point scale. | Effect on Blood sugar - fasting and post prandial, glycosylated haemoglobin
Effect on Blood sugar - fasting and post prandial at the interval of 2 weeks till 12 weeks. Effect on glycosylated haemoglobin (HbA1c) at base line and 12 weeks.
时间窗: Effect on symptoms of Prameha according to four point scale. | Effect on Blood sugar - fasting and post prandial, glycosylated haemoglobin
次要结局
- Effect on lipid profile, Haemogram, Renal profile, Hepatic Profile at the base line and at 12 weeks. Effect on weight and body mass index (BMI) at the interval of 2 weeks till 12 weeks(At base line and 12 weeks.)