Randomised controlled clinical trial to evaluate the hypoglycemic effect of kaidarya patra swrasa in madhumeh with special reference to hyperglycemia in Diabetes mellitus 2
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the hypoglycemic effect of kaidarya patra swarasa in madhumeha with
研究概览
简要总结
Randomised controlled clinical trial.
This study is conducting for to evaluate the hypoglycemic effect of kaidarya patra swrasa in madhumeh with special reference to hyperglycemia in Diabetes mellitus type 2.
According to ayurveda increase in frequency, quantity and turbidity of urine are the cardinal signs and symptoms of Prameha. (Va.Ni.10/7).
Vitiated Dosha’s disturb the metabolism of Meda and Mansa Dhatu (i.e. disturbed carbohydrate, fat and protein metabolism). Kapha Dosha along with these vitiated Dhatus and vikruta kleda vitiate Basti to manifest 20 types of Prameha.
All 20 types of prameha if not treated can leads to madhumeha.Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the
phenotype of hyperglycemia. Several distinct types of DM are caused by a complex
interaction of genetics and environmental factors. Depending on the etiology of the DM,
factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose
utilization, and increased glucose production. The metabolic dysregulation associated with
DM causes secondary pathophysiologic changes in multiple organ systems that impose a
tremendous burden on the individual with diabetes and on Health care system.
DM is the leading cause of end-stage renal disease non traumatic lower-extremity
amputations, and adult blindness. Persons with diabetes are at increased risk for
cardiovascular disease, which is the main cause of morbidity and mortality in this
population. (Harrison p.o.i.m Page no.3094. 21 st edition)(
Recent figures r have shown that 77. million people currently have H diabetes in India, and this number is projected to rise to a 101.2 million by 2030. (RSSDI text book of Diabetes mellitus. Page no.169.)
According to IDF Atlas 10th Edition 2021. where diabetes prevalence was estimated at
9.6% in 2021and 15%in 2015and 19% in 2019 According to pubmed..
Hyperglycemia in diabetic should be assessed aggressively & treated to avoid many
microvascular & microvascular risk factors of hyperglycemia & it’s complications like
Diabetic Retinopathy, diabetic nephropathy, diabetic nephropathy, cardiovascular disease,
cerobrovescular disease, peripheral vascular disease. (RSSDI text book of Diabetes mellitus.
page no. 169. 3rd edition)
Previous Research work shows that Reduction of hyperglycemia significantly reduces cardiovascular events Diabetic complications & morbidity in individual with DM-2
Null hypothesis. - Kaidaryapatra swarasa. 20 Ml twice a day for 30 days is not significantly effective in
Madhumeha with special reference to hyperglycemia in Diabetes mellitus 2.
Alternate hypothesis -
Kaidaryapatra swarasa. 20 Ml twice a day For 30 days is significantly effective in
madhumeha with special reference to hyperglycemia in Diabetes mellitus -2.
Formulation - kaidarya patra swaras
Dose- 20 ml twice a daily orally .
Anupana - koshna jal
Sevankala- apan kaal . bid . Before Lunch &before Dinner
Duration - 30days
Follow up- 15 th day, & 30th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients irrespective of gender having age between 21 yrs to 60yrs Patients having clinical signs and symptoms of madhumeha with special reference to hyperglycemia in DM-2 BSL-fasting up to 150 mg/dl or Post prandial up to 250 mg/dl Or both.
排除标准
- •Pregnant and Lactating mothers.
- •Patients with serious illness like HIV, Malignancy T.B., Major Liver disorders End stage Renal disease.
- •Individuals recently undergo major surgery known case of diabetes mellitus type 1 gestational diabetes mellitus diabeticketoacidosis diabetic coma, Neurogenic ulcer peripheral vascular disease.
- •acute infection any where in the body and gangrene.
- •patients on insulin therapy and steroid therapy.
结局指标
主要结局
To assess the hypoglycemic effect of kaidarya patra swarasa in madhumeha with
时间窗: 15th day , 30th day
special reference to hyperglycemia in Diabetes mellitus -2
时间窗: 15th day , 30th day
次要结局
- To assess the hypoglycemic effect of kaidarya patra swarasa in madhumeha with special reference to hyperglycemia in Diabetes mellitus -2
研究者
Dr Atul Maroti Pariskar
Seth Aryangla vaidyak Mahavidyalay satara