Ayurveda Based Diet and Behavioral Lifestyle Intervention For Management of Pre-Diabetes-A Community Based Study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Ayurvedic Diet Therapy (ADT) and Ayurveda Behavioral Lifestyle Intervention (ABLI) in reducing HbA1c levels among individuals with prediabetes.
研究概览
简要总结
Title
Ayurveda Based Diet and Behavioral Lifestyle Intervention for Management of Prediabetes
A community based study.
Study Focus
A community based study evaluating Ayurvedic dietary and lifestyle interventions for managing prediabetes in the Oachira block, Kollam district, Kerala.
Background India, with a high prevalence of diabetes, faces an urgent need for preventive measures. Kerala, with a 19 percent diabetes prevalence, exhibits a higher rate of prediabetes than diabetes. Ayurveda offers a promising approach to reversing prediabetes with its focus on Kapha dominance, which aligns with early diabetic symptoms.
Primary Objective To assess the efficacy of Ayurvedic Diet Therapy (ADT) and Ayurveda Behavioral Lifestyle Intervention (ABLI) in reducing HbA1C levels in individuals with prediabetes.
Secondary Objectives:
Impact on BMI, waist circumference, and weight loss.
Compliance with Ayurvedic interventions.
Methodology
Population
1000 prediabetic individuals aged 35-60 identified via the Indian Diabetes Risk Score (IDRS) and HbA1C testing.
Interventions
ADT (herbal drink-Asana toya, Triphala tablets) and ABLI (Udwartana, yoga, lifestyle counseling).
Design
Pre and post study with follow ups every four months for one year.
Outcome Measures
Changes in HbA1C, BMI, and waist circumference.
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
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Either Sex, Age.
- •35-60, at moderate or high risk for diabetes by Indian Diabetic Risk Score, Pre-diabetic range-5.7%â€6.4% by HbA1c, BMI indicating overweight or obese status.
排除标准
- •H/o Uncontrolled Hypertension, renal disease, severe heart disease, heart failure, cancer or any serious illness compromising the ability of subject to participate/comply with or complete the study.
结局指标
主要结局
To assess the efficacy of Ayurvedic Diet Therapy (ADT) and Ayurveda Behavioral Lifestyle Intervention (ABLI) in reducing HbA1c levels among individuals with prediabetes.
时间窗: Every 4 months HbA1c will be assessed
次要结局
- To evaluate the impact of ADT and ABLI on BMI, waist measurement, and weight loss among individuals with prediabetes.(every 4 months weight, BMI will be assessed.)
- To assess compliance with diet and lifestyle modifications among participants.(every 4 months)
研究者
Dr Delvin T Robin
Amrita School of Ayurveda