A Prospective, Open Label Single-Arm Clinical Study to Assess the Efficacy and Safety of D-PRIO®, a herbal formulation on patients with Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mean levels of Blood Glucose (Fasting and Post Prandial) and Glycated hemoglobin (Hb1Ac)
研究概览
简要总结
This study is an Open Label, Single- Arm, Prospective, Intervention Study, single-centre trial studying the safety and efficacy of D-Prio (475 mg capsules) twice daily for 3 months in 30 patients with Type 2 diabetes mellitus that will be conducted in only one center in India. The primary outcome measures will be Change in mean levels of Blood Glucose levels (Fasting and Post Prandial) and Glycated hemoglobin (Hb1Ac) measured from baseline (before start of treatment) to the end of treatment (Day 90). The secondary outcomes will be Change in Fasting and Post prandial blood glucose levels after every 15 days upto 3 months; Change in Body weight, BMI and Diastolic and Systolic at the end of every month; Change in Total cholesterol, HDL, LDL, Triglycerides, SGPT, SGOT, Bilirubin and Creatinine on Day 90 (end of treatment) as compared to baseline (before treatment levels). Mean change in QoL status will be determined before treatment and at the end of every month. Patient’s Global Assessment of Tolerability to Therapy (PGATT) score will be assessed at the end of study. Number and proportion of Treatment Emergent Adverse Events (TEAEs) will be noted during the complete trial/study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males and females of ages ≥ 18 years and ≤60 years
- •Patients who can and willing to provide written Informed Consent.
- •Patients suffering from Type-2 Diabetes of less than 10 years duration
- •Patients with HbA1c >6.5% and <9%
- •Patients with fasting plasma glucose >126 mg/dL and <180 mg/dL
- •Patients with Body mass index: 25-34.9 kg/m2
- •Participant who agree to take Investigational product (IP) till Day
- •Patients willing to be on a restricted diet (no sugary foods or drinks, no sugar in tea or coffee, no honey, no rice, no white bread, no potatoes, no fried meat/fish, no banana and mangoes) during the duration of the study
- •Patients having capability of complete compliance and completion of follow-up
- •Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1.Patients on current prescription of any medicine for Diabetes or any drug that impacts glucose level 2.Patients with diabetes other than Type 2 diabetes mellitus 3.Patients having a history or presence of clinically relevant cardiovascular renal thyroid metabolic hematological neurological psychiatric systemic or infectious disease or malignant tumor 4.Patients suffering from any Bleeding disorders or Glucose 6-Phosphate Dehydrogenase deficiency 5.Patients with severe mental disorder 6.Patients with recent hospitalization for major illness or elective surgery within 1 year of the start date of study 7.Female patients with pregnancy or lactation or intention to become pregnant and not using appropriate contraceptive methods 8.Patients with terminal illness 9.Patients with history of alcoholism or substance abuse 10.Patients who are not willing to take investigational product 11.Patients with known history of sensitivity or allergy to any herbs or herbal products 12.Patients on dietary supplements or multivitamins or disease specific oral nutrition supplements 13.Patients with uncontrolled or unstable comorbidities 14.Patients with respiratory conditions or diagnostic history with chronic lung disease or active malignancy or chronic kidney disease or chronic liver disease 15.Patients taking part in any other studies including macro or micro or any other forms of dietary supplements or multivitamins or disease specific oral nutrition supplements 16.Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled or unstable comorbidities 17.Patients who had participated in other clinical trials during previous 3 months.
结局指标
主要结局
Change in mean levels of Blood Glucose (Fasting and Post Prandial) and Glycated hemoglobin (Hb1Ac)
时间窗: at baseline, 90th day
次要结局
- Change in Fasting and Post prandial blood glucose levels after every 15 days upto 3 months; Change in Body weight, BMI and Diastolic and Systolic at the end of every month; Change in Total cholesterol, HDL, LDL, Triglycerides, SGPT, SGOT, Bilirubin and Creatinine on Day 90 (end of treatment) as compared to baseline (before treatment levels). Mean change in QoL status will be determined before treatment and at the end of every month. Patient’s Global Assessment of Tolerability to Therapy (PGATT) score will be assessed at the end of study. Number and proportion of Treatment Emergent Adverse Events (TEAEs) will be noted during the complete trial/study duration(Every 15 days, some parameters at the end of every month, and some at the end of 3 months)