An Open-labelled, Single Arm, Interventional Clinical Study to Evaluate the Efficacy and Safety of NATBERB (100% Natural Berberine) as an adjuvant therapy in Type 2 Diabetes mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate Changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting
研究概览
简要总结
An Open-labelled, Single Arm, Interventional Clinical Study to Evaluate the Efficacy and Safety of NATBERB (100% Natural Berberine) as an adjuvant therapy in Type 2 Diabetes mellitus.Treatment group: Subjects with Type 2 Diabetes Mellitus will be administered with Berberine.Total of 30 subjects.Visit 1/Day 0- ICF and Screening procedures such as; Hematological Investigations, Serological Investigations, Urinalysis and UPT ï‚· Visit 2/Day-1-Enrollmentï‚· Visit 3/Day 15-, FBS, PPBS ï‚· Visit 4/Day 30-FBS, PPBS ï‚· Visit 5/Day 45- FBS PPBS ï‚· Visit 6/Day 60 EOS In-person visit- repeat of all screening procedures such as; Hematological Investigations, Serological Investigations, Urinalysis and UPT
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex between the age group 18 to 55 years(both inclusive).
- •Patients who are diagnosed as suffering from Type 2 Diabetes mellitus.
- •Patients with HbA1c ≥ 7.0%.
- •Subjects with Body Mass Index (BMI) >27 kg/m2 and<45 kg/m2.
排除标准
- •1.Type 1 diabetes mellitus 2.Patients with severe hyperglycemia (FBS >240 mg% or PPBS >360 mg%) 3.Patients with fasting serum cholesterol >260mg% and serum Triglycerides>300 mg%.
- •4.Patients with HbA1c more than 10.5 %.
- •5.Patients with ASAT and ALT levels greater than 2.5 times the upper normal limits 6.Severe renal, hepatic or respiratory disorder.
结局指标
主要结局
To evaluate Changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting
时间窗: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60
blood sugar and post prandial blood sugar.
时间窗: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60
次要结局
- To observe the quality of life by evaluating the reduction in Body mass index (BMI) and(changes in lipid profile, TSH, Serum creatinine and bilirubin.)