A Prospective, open-label clinical study to evaluate the safety and efficacy of Auretics Sugar Management Spray in stabilizing blood glucose levels in Diabetic patients.
试验速览
- 阶段
- 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
- Primary out Come:
研究概览
简要总结
Type 2 diabetes mellitus (DM) has become a significant global health issue, attracting increasing attention due to its widespread impact. It is anticipated to remain a major public health challenge, often leading to severe complications. India ranks among the top five countries with the highest prevalence of diabetes.
In Ayurveda diabetes is called as Prameha. There are twenty types of prameha:
1)Kaphaja Prameha – which includes Ten types – early stage Overweight with mild hyperglycaemia. - Polyuria/ glycosuria
2)Pittaja prameha – which includes six types – Acute stage
Loss of weight. - Hyperglycaemia and glycosuria - urinary tract infection
3)Vataja Prameha – which includes four types – Chronic stage.
•Severe hyperglycaemia with glycosuria (Chronic diabetes)
•Nephropathy neuropathy - Retinopathy – Gangrene
Auretics Sugar Management Spray helps reduce increased blood sugar and increase insulin levels after meals, helps lower fasting blood glucose levels by enhancing the insulin activity and sensitivity andhelps strengthen pancreas and increases insulin secretion, making the body more responsive to insulin. Our formulation Auretics Sugar Management Spray contains all active natural ingredients. These natural ingredients in common have capacity to lower the blood sugar levels.
Also this product is applied through external route that is topical absorption. Transdermal drug delivery systems have been explored for diabetes management, offering a non- invasive alternative to injections. These systems deliver medications through the skin to help regulate blood sugar levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject Between 30 years to 60 years of both genders.
- •Diabetic subjects on anti diabetic medication.
- •Subject who are hypertensive
- •Subject free from infection, cancer and other diseases
- •Subject willing to give written Informed Consent 6.FAsting Blood Glucose level between 110 mg/dl to 250 mg/dl 7.Post Parandial Blood Sugar level between 140 mg/dl to 350 mg/dl.
排除标准
- •1.Subjects with diabetes mellitus along with other comorbid conditions.
- •2.Pregnant or lactating women
- •Women of childbearing potential who do not take adequate contraceptive protection 4.History of hypersensitivity to the metformin or to drug with similar chemical structure 5.History of any severe systemic disease 6.Patients with uncontrolled hypertension 7.History of stroke, cancer, acute illness.
结局指标
主要结局
Primary out Come:
时间窗: Evaluation from baseline to day 30, day 60 and day 90
1.To evaluate the efficacy of Auretics Sugar Management Spray in stabilizing Blood Sugar in Diabetic patients.
时间窗: Evaluation from baseline to day 30, day 60 and day 90
2. Decrease in Blood Sugar Level- Fasting blood sugar (FBS), Post Prandial Blood Sugar (PPBS) Glycated hemoglobin (HbA1c) and Urine Sugar from Day 0 to Day 90
时间窗: Evaluation from baseline to day 30, day 60 and day 90
次要结局
- Secondary Outcome:(To evaluate the safety and consumer acceptance of Auretics Sugar Management Spray in stabilizing blood glucose levels in Diabetic patients through feedback questionnaires)