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临床试验/CTRI/2024/07/070065
CTRI/2024/07/070065尚未招募不适用

A Cross Sectional Analytical Study To Evaluate the Purvarupa of Prameha in Pre Diabetes and Diabetes Mellitus

Dr Sanjay Gamaji Paikrao1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
-Urine Sugar fasting

研究概览

简要总结

Title: A Cross Sectional Analytical Study To Evaluate the Purvarupa of Prameha in Pre Diabetes and Diabetes Mellitus.

Prameha is a chronic life style disease explained in Ayurved by Acharya Charaka 1000 BC, if it is not diagnosed in early stage and not properly treated then all types of Prameha (20types) ultimately morph into madhumeh which is incurable disease and can be produces serious complications in different parts of the body.            Some studies show the purvarupa of prameha (prodromal features) are associated with pre diabetes and some studies shows prameha purvarupa are related with diabetes. This study will help to find the actual association among them.

 Patients diagnosed with pre diabetes or diabetes mellitus and fulfilling inclusive criteria will be selected and divided in to two group, Group 1 pre Diabetes (80) & group 2 Diabetes (80)with appropriate sample size. Then the patients in each group will be examined for  prameha purvarupa with objective parameters and subjective parameters and data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) &percentage (%) of categorical data, mean & Standard deviation of numerical data in each group / subgroup will be depicted.  Frequency (n) & percentage (%) of various categories in each group / sub group  will be compared using chi square test. Odds ratio, likelihood ratios & chi square test to check the association between the risk factor and disease. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

 With statistical analysis conclusion will be made that whether the Prameha purvavsta is associated with pre diabetes or diabetes mellitus. Clinically it is difficult to diagnose a Prameha in Purvrupavastha due to subjective prodromal features explained in Ayurved samhitas. If we could find the association of  Purvrupa of Prameha with pre diabetes or diabetes mellitus, with the help of laboratory investigations, we may able to diagnose a purvarupavstha of Prameha timely. It will help us to treat Prameha patients in a prodromal state of the disease, it will guide us to suggest the preventive aspect of the disease and thus this study will help us to avoid premeha updravas (complications).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed Patients of prediabetes and diabetes Mellitus type 2 with 2.IFG( Impaired fasting glucose)BSL fasting More than 100 Mg/dl 3.IGT (Impaired glucose tolerance ) BSL PP More than 140 mg/dl 4.Oral glucose tolerance (0GTT) after 2 hr more than 140 5 HbA1c more than 5.7 %.

排除标准

  • 1.Pre Diabetes, diabetes mellitus patients in pregnant women 2.patients below 18 and mote than 70 3.Patients suffering from major illness like HIV HBV 4.Non cooperative patients.

结局指标

主要结局

-Urine Sugar fasting

时间窗: 8 days

-Urine sugar PP

时间窗: 8 days

-Blood sugar level fasting

时间窗: 8 days

-Blood sugar level PP

时间窗: 8 days

-HbA1c

时间窗: 8 days

次要结局

  • -Indian Diabetes Risk Score (IDRS)(Features of Prameha Purvarupa)

研究者

发起方
Dr Sanjay Gamaji Paikrao
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Sanjay Gamaji Paikrao

APMs Ayurved Mahavidyalaya and Hospital

研究点 (1)

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