Evaluation of two ready-to-cook dietary supplements for its anti-diabetic property in patients of type-2 diabetes mellitus -A Randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Fasting blood glucose (minimum 8 hrs after dinner), Post prandial blood sugar (2 hours after breakfast), Plasma Insulin and HOMA-IR
研究概览
简要总结
A diet is a combination of foods, individual or community habitually eats to exist or live, or use for therapeutic purposes. Conventionally type-2 diabetes is controlled with diet alone or diet and hypoglycemic agents. American Diabetes Association has defined self-dietary management as the key step in providing the diabetics, the knowledge and skill in relation with treatment, nutritional aspects, medications and complications. Dietary management of diabetes is not only known to achieve optimal blood glucose but also provide energy and prevent or delay diabetic complications.(1)
Various studies have reported bio-active phyto-chemicals in various herbs used as food. The global concern for diversification of these foods to improve therapeutic use for diabetes control by enhancing the beneficial constituents in them has risen. There is a need to integrate these potential foods within innovative systems in accordance with local needs, food habits and priorities.
Considering the busy life of people these days, two ready-to-cook formulations were proposed to be developed to evaluate its efficacy in lowering blood glucose level and also to analyse its effect on Agni (Appetite or digestion) if any. The ingredients used in these formulations will be FSSAI certified and a standardized product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex, 18-60 years.
- •Known diabetic subjects with fasting blood glucose between 150mg/dL-200mg/dL(both values included) and/or post prandial blood glucose between 180mg/dL -300mg/dL (both values included) III.
- •Subjects who are on stable dose of any OHA (Oral hypoglycemic agent).
- •Subjects who agree to participate in the study and submit a written informed consent form.
排除标准
- •Subject diagnosed with type 1 Diabetes Mellitus.
- •Subjects who are on Insulin therapy.
- •Patients with confirmed diagnosis of diabetic complications like diabetic retinopathy, neuropathy, nephropathy, non-healing wounds, gangrene/ amputed limbs/toes.
- •Subjects with Haemoglobin percentage less than 8 g/dl.
- •Subjects with uncontrolled hypertension (with or without medication systolic more than 150 and/or diastolic more than 100 mmHg after 10 minutes of rest) VI.
- •Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
- •Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) VIII.
- •Subjects with Renal Dysfunction (defined as eGFR less than 60 ml/min.
- •Subjects with Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids.
- •Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy.
- •Pregnant / Lactating women.
- •Subjects on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
- •Subjects with current diagnosis of malignancy or in last five years.
- •Subjects who have completed participation in any other interventional clinical trial during the past three months.
- •Any other condition which the Investigator thinks may jeopardize the safety of the subject.
结局指标
主要结局
Change in Fasting blood glucose (minimum 8 hrs after dinner), Post prandial blood sugar (2 hours after breakfast), Plasma Insulin and HOMA-IR
时间窗: Baseline and 42nd day
次要结局
- 1. Change in BMI and waist circumference(Baseline and 42nd day)
- 2. Change in Lipid profile(Baseline and 42nd day)
- 3. Change in renal function, liver function, hematology, urine analysis(Baseline and 42nd day)
- 4. Any SAE /ADR or change in laboratory parameters(Baseline and 42nd day)
- 5. Change in Symptoms – Diabetes Symptom questionnaire (DSQ)(Baseline and 42nd day)
- 6. Change in Symptoms - Simplified nutritional appetite questionnaire (SNAQ(Baseline and 42nd day)
- 7. Change in Agni - Agni assessment tool developed by CCRAS(Baseline and 42nd day)
- 8. Acceptability of the ready-to-cook dietary supplement(21st day)
研究者
Dr Sulochana Bhat
Central Ayurveda Research Institute