A Clinical Study To Evaluate The Efficacy Of Holistic Berberine In The Management Of Madhumeha(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
- 50
- 试验地点
- 1
- 主要终点
- 1.The patient will be assessed based on their body weight, BMI, Body circumference measurements of certain regions 2. Investigations: Complete Lipid profile, HbA1C
研究概览
简要总结
A clinical study will be conducted to evaluate the efficacy and safety of Zeroharm Holistic Berberine tablets, an Ayurvedic formulation, in individuals diagnosed with Type 2 Diabetes Mellitus.
Participants who meet the eligibility criteria will receive the investigational product once daily for a period of three months. Two follow-up visits will be scheduled at monthly intervals to monitor progress and treatment response.
Baseline and post-treatment laboratory assessments will be performed to evaluate clinical outcomes. Key parameters will include:
Body weight, Body Mass Index (BMI), and waist circumference
Lipid profile, HbA1c, and other metabolic markers
The study will also record any adverse events to ensure participant safety throughout the intervention. Patient compliance and tolerability of the Ayurvedic formulation will be closely monitored.
All collected data will be subjected to statistical analysis to determine the significance of observed changes. The primary aim of this study is to validate Zeroharm Holistic Berberine as a safe, natural, and effective support for metabolic health and weight management in individuals with Type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with glycosylated hemoglobin HbA1c graterthan 6.5%.
- •Patients recently diagnosed with uncomplicated non-insulin-dependent diabetes mellitus type 2 diabetes and having the following criteria fasting blood sugar level grater than 126 mg/dL and less than 250 mg/dL, and post-meal blood sugar level greaterthan 200 mg/dL.
排除标准
- •patients having age lower than 18 and higher than 70 years patients are pregnant and lactating women.
结局指标
主要结局
1.The patient will be assessed based on their body weight, BMI, Body circumference measurements of certain regions 2. Investigations: Complete Lipid profile, HbA1C
时间窗: 12 weeks
次要结局
- 1. Weight management (measured by BMI).(2. Quality of life (measured by the Short Form Health Survey - SF-36).)
研究者
Dr Shyamanta Kalita
Govt Ayurvedic College and Hospital