An exploratory comparative clinical study to assess the impact of 24-hour fermented millet Ambali powder with or without herbal kwatha in managing Type-2 Diabetes in elderly individuals
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in managing Type-2 Diabetes in elderly individuals.
研究概览
简要总结
A multiple centre, prospective randomized open label trial with sample size of 80 divided in two group as 40 in each. Group A will be given heat killed probiotic 8 millet Ambali Powder with diet having 8 positive millets in individuals with diabetes for three month of duration and group B will be giiven Heat killed probiotic 8 millet Ambali powder with diet having sprouted wheat and herbal Kwath (Kadha) of leaves of Moringa, Pudina, Coriander, Giloy, Jamun & Methi in individuals with diabetes for three-month duration.
Primary Objectives – To evaluate the efficacy of 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha in managing Type-2 Diabetes in elderly individuals
Secondary Objectives- To evaluate the efficacy of 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha in reduction of blood sugar fasting level, Uric acid, HbA1C, increase in Vitamin B12 and changes in LFT, KFT and lipid profile parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetes subjects of both sex of age group of 60-70 years.
- •Fasting blood glucose level 121-250 mg/dL.
排除标准
- •Subjects with food allergy, chronic diseases or on life saving medication pregnant/ lactating women.
- •smokers consuming more than 2 alcohol serving per week.
结局指标
主要结局
24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in managing Type-2 Diabetes in elderly individuals.
时间窗: 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in managing Type-2 Diabetes in elderly individuals.
次要结局
- 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in the reduction of blood sugar fasting level, Uric acid, HbA1C, increase in Vitamin B12 and changes in LFT, KFT and lipid profile parameters Safety Recording(03 months)
研究者
Prof Pradeep Kumar Prajapati
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur