Effectiveness of selected Ayurvedic treatment protocol in type 2 Diabetes Mellitus
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in the score of variables FBS, PPBS, HbA1C.
研究概览
简要总结
Diabetes Mellitus(DM) also called as Diabetes, refers to a group of metabolic diseases characterized by abnormal glucose homeostasis resulting in elevated blood sugar. It is considered as one of the largest global emergencies of this century. the most common type is type 2 DM, usually seen in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. According to International Diabetes federation (IDF), diabetes affects an estimated 537 million people worldwide. It is projected that, by 2030, 643 million people will have diabetes worldwide, increasing to 783 million by 2045. The burden of Type 2 DM in India is massive, and with 77 million people, the country ranks second for having the highest number of Type 2 DM patients in the world, following china. Based on a study conducted by ICMR, the prevalence of diabetes in India is 11.4%. Kerala is at third position after Goa and Puducherry with prevalence rate of 23.6%. Prameha is a well known clinical syndrome since time immemorial. The word Prameha was first mentioned in Caraka samhitha, which is akin to Diabetes. It is a kapha pradhana tridoshajanya vyadhi in which medas is the pradhana dooshya. It is characterised by Prabhoota avila mootrata which means frequent and turbid urination. Based on the predominance of dosas, 20 types of prameha are mentioned in all classics. Among them, the most important disorder is madhumeha. A subtype of madhumeha i.e., avarajanya madhumeha ma be correlated to Type 2 Diabetes mellitus. The objective of this study is to determine the effectiveness of selected Ayurvedic treatment protocol in Type 2 Diabetes Mellitus. In this study, the participants will be selected and assigned under a single group. The study is of interventional type. Both male and female participants of age group 30-60 years with FBS level from 150-250mg/dL and PPBS level from 200-350mg/dL, attending the OPD and IPD of Government Ayurveda College, thiruvananthapuram will be selected for the study. the required laboratory investigations will be done before and after the study period. The collected data will be subjected to statistical analysis using appropriate statistical techniques. Results will be drawn, summarized and conclusions will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Male and female participants of age group between 30-60 years 2.Participants with history of Type 2 Diabetes Mellitus 3.Participants with FBS value from 150-250mg/dl and PPBS value from 200-350mg/dl 4.Participants with HbA1C ≥ 6.5% & ≤ 9%.
排除标准
- •1.Known cases of any serious systemic illness under medication 2.Pregnant and lactating women 3.Participants on steroids/oral contraceptive pills/oestrogen replacement therapies.
- •4.Undergone GI Surgeries/Malignancies 5.Type 1 DM/on insulin therapy.
结局指标
主要结局
Changes in the score of variables FBS, PPBS, HbA1C.
时间窗: 0th day and 91st day
次要结局
- Improvement in Quality of life- will be assessed by - QOLID(0th day & 91st day)
研究者
Dr Aysha Subinam S
Government Ayurveda College, Thiruvananthapuram
