Clinical Evaluation of Diabic Care Juice in the management of Type II Diabetes Mellitus (Madhumeha)in newly diagnosed patients.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- 1. Change in Glycemic assessment (FPG and PPG) from Baseline to Week 4, Week 8 and Week 12.
研究概览
简要总结
This single-arm, multicenter study aims to assess the efficacy and safety of Diabetic Care Juice in 30 male and female diabetic patients aged 18-70 years, newly diagnosed within the last six months and not on any oral antidiabetic medications. The study involves four site visits: Day 0 (Screening & Baseline), Week 4, Week 8, and Week 12. Patients will consume 30 ml of Diabetic Care Juice twice daily for three months. Fasting blood glucose and postprandial glucose will be measured at all four visits, while HbA1c, lipid profile, liver function, and renal function tests will be conducted at the screening and end-of-study visits.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male and female patients aged between 18-70 years with BMI range of 18 to
- •Newly diagnosed or recently diagnosed (last 6 months), not taking any oral antidiabetic medications.
- •Patients with HbA1c of greater than or equal to 6.5% to less than or equal to 8.9% IV.
- •Ready to provide written informed consent form.
- •No History of any known allergy with Diabic Care Juice like products or any other ingredients.
- •Willing to come for follow up visits for evaluation.
- •No significant medical/surgical disease/s at the time of screening.
排除标准
- •Presence of any clinically significant medical or surgical condition requiring long term treatment.
- •Patients who are currently using the AYUSH related medications.
- •Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc IV.
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 3 months V.
- •Patients with concurrent serious Hepatic Dysfunction defined as AST and ALT more than 3 times of the upper normal limit or Renal Dysfunction defined as S.
- •creatinine more than 1.2mg per dl, uncontrolled or other concurrent severe disease.
- •Patients participating or participated in another clinical study within 3 months before recruitment.
- •Pregnant or Lactating women.
- •Patient on steroids, oral contraceptive pills.
结局指标
主要结局
1. Change in Glycemic assessment (FPG and PPG) from Baseline to Week 4, Week 8 and Week 12.
时间窗: Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 and Visit 4 Week 12
2. Change in Glycated hemoglobin (HbA1c) from Baseline to Week 12.
时间窗: Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 and Visit 4 Week 12
次要结局
- 1. To assess change in Symptoms Diabetes Symptoms Questionnaire (DSQ)(2. To assess change in Lipid profile, Liver function & Renal function test values from baseline to 12th week.)
研究者
Dr Sanjay Mishra
Rumedic Hospital