Evaluation of Efficacy of Tab.Glucitox in Patients of type 2 Diabetes Mellitus
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- glycaemic control (measured by glycosylated haemoglobin A1c (HbA1c) and fasting blood glucose levels)
研究概览
简要总结
**Title-**Evaluation of Efficacy of Tab.Glucitox in Patients of type 2 Diabetes Mellitus,
**Objective -**The objective of the study is to evaluate the efficacy and safety of Tab.Glucitox in Patients of type 2 Diabetes Mellitus
**Primary Outcome:-**glycaemic control (measured by glycosylated haemoglobin A1c (HbA1c) and fasting blood glucose levels); 2. health-related quality of life **Secondary Objectives :**Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters , Assessment of clinical global evaluation for overall efficacy by physician and by the patient
study group- open randomized study
sample size -50
Dose -tab.Glucitox 1 TDS for 8 weeks
**Visit Schedule-**0th day . 15th day, 3OTH DAY ,45 TH DAY ,60 TH DAY
**Inclusion criteria-**1. Confirmed case of DM (NIDDM / TYPE II Diabetes Mellitus) 2. Both sexes 3. Uncomplicated 4. Age between 30 yrs to 65 yrs old 5.fasting blood sugar more than 125mg/dl 5.post-prandial blood sugar more than 200mg/dl ,HBA1c between 7 to 10 %
exclusion criteria - blood sugar more than 400mg/dl ,preganancy and lactating mother, complications like diabetic neuropathy,retinopathy,nephropathy m maliganancy , CVS disoders
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed case of DM (NIIDDM or Type II DM) Uncomplicated Fasting BSL more than 125mg/dl less than or equal to 200mg/dl PP BSL more than 200mg/dl equal to or less than 400mg/dl HbA1c more than 7 % and 10 % Patients with informed written consent.
排除标准
- •Blood sugar more than 400mg/dl,preganancy and lactating mothers,complications like hyperglycemic coma,ketoacidosis ,DM Neuropathy,retinopathy ,neuropathy ,Malignancy ,CVS disorders.
结局指标
主要结局
glycaemic control (measured by glycosylated haemoglobin A1c (HbA1c) and fasting blood glucose levels)
时间窗: 2months
次要结局
- Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters ,Assessment of clinical global evaluation for overall efficacy by physician and by the patient ,(Assessment of overall acceptability/tolerability by Subject and physician)
研究者
DrAshish Hasuram Mhatre
D.Y.PATIL DEEMED TO BE UNIVERSITY,SCHOOL OF AYURVEDA NERUL NAVIMUMBAI