Development and comparative clinical study of a convenient ready to cook antidiabetic meal using Pramehahara Dravyas in the management of type 2 diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. A ready to cook Ayurvedic meal for diabetes mellitus will be developed.
研究概览
简要总结
Diabetes is an iceberg disease. Although increase in both the prevalence and incidence of type 2 diabetes have occurred globally they have been especially dramatic in societies in economic transition in newly industrialized countries and in developing countries. In the fast evolving urban lifestyle where people do not have enough time to prepare healthy foods every day the demand for ready to cook foods is rising. Most of the people with diabetes come under this category. Thus in the era of fast food and preserved food items it is the need of the hour to come up with Ready to Cook Rice Meal for Diabetes incorporating the Ayurvedic principles told for diabetes. A ready to cook meal free from all kinds of preservatives freshly prepared in a short duration of time can become a very convenient go to meal. This rice meal is incorporated with Pramehahara ingredients told in Ayurveda and is enriched with the required nutrients for a diabetes patient.
The present study is a single blind controlled comparative study with pre test and post test design which aims at developing a ready to cook ayurvedic antidiabetic meal and comparing its efficacy with already existing medicine for diabetes which is Nishamalaki Vati. A total of 30 patients diagnosed with type 2 diabetes mellitus will be selected fulfilling inclusion criteria for the study after subjecting them to thorough clinical examination as per the proforma prepared for the study irrespective of gender religion and socioeconomic status. 30 newly diagnosed patients of type 2 diabetes mellitus selected as per the inclusion criteria will be randomly allocated in Group A and Group B. Group A will receive the ready to cook Ayurvedic anti diabetic meal twice daily for a period of 8 weeks and Group B will receive Nishamalaki Vati 500mg twice daily for a period of 8 weeks. Duration of the study will be 8 weeks for both groups. Follow up on 4th week during the study.
Objectives of the study include
1. Development of ready to cook Ayurvedic meal for diabetes mellitus.
2. To study the effect of the ready to cook Ayurvedic anti-diabetic meal in the management of type 2 Diabetes mellitus.
3. To study the nutritive value of the developed ready to cook Ayurvedic anti diabetic meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of age group of 18 to 45 newly diagnosed cases of type 2 diabetes mellitus with HbA1c between 5.7 and 7.5 per cent.
排除标准
- •Any systemic illness which hampers the outcome of the study
- •Pregnant women and lactating mothers.
结局指标
主要结局
1. A ready to cook Ayurvedic meal for diabetes mellitus will be developed.
时间窗: Subjective and objective criteria will be assessed at baseline, 4 weeks & 8 weeks
2. The effect of the ready to cook Ayurvedic anti diabetic meal in the management of type 2 Diabetes mellitus will be identified.
时间窗: Subjective and objective criteria will be assessed at baseline, 4 weeks & 8 weeks
3. The nutritive value of the developed ready to cook Ayurvedic anti diabetic meal will be assessed.
时间窗: Subjective and objective criteria will be assessed at baseline, 4 weeks & 8 weeks
次要结局
未报告次要终点
研究者
Dr K Shreeraksha
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Udupi