clinical study to evaluate the Efficacy of Fat Burner in the management of obesity
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
- Change in body weight and fat mass. Result will be assessed on the basis of body weight, BMI, Body circumference measurements of certain regions.
研究概览
简要总结
A clinical study will be conducted to assess the efficacy and safety of Zeroharm Fat Burner tablets, an Ayurvedic formulation, in individuals with obesity.
Eligible participants will be administered the tablets daily for a period of three months.
Two follow-up visits will be scheduled at 1-month intervals to monitor patient progress.
Baseline and post-treatment laboratory tests will be conducted to evaluate clinical outcomes.
Key parameters will include body weight, BMI, waist circumference, lipid profile, and metabolic markers.
Changes in appetite, energy levels, and physical activity tolerance will also be recorded.
The study will monitor for any adverse effects and ensure patient safety throughout.
Patient compliance and tolerability of the Ayurvedic formulation will be assessed.
Data will be statistically analyzed to determine the effectiveness of the treatment.
The study aims to validate Zeroharm Fat Burner as a safe and natural aid for weight management.
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
- •subjects having BMI more than 30 kg/m2 and lower than 40 kg/m2 Subjects not suffering from any significant illness (medical or surgical) Subjects not not currently taking weight loss medications or supplements.
排除标准
- •Subjects below 18 years or above 60 years of age Patient having very high level of dyslipidaemia Individuals with a history of cardiovascular disease, liver or kidney dysfunction, or those taking medications affecting weight.
结局指标
主要结局
Change in body weight and fat mass. Result will be assessed on the basis of body weight, BMI, Body circumference measurements of certain regions.
时间窗: 12 weeks
次要结局
- 1. Changes in metabolic markers (blood glucose, lipid profile, inflammatory markers) 2.Assessment of appetite and satiety (using validated questionnaires). 3. Evaluation of side effects and overall safety through regular monitoring.(12 weeks)
研究者
Dr Pranabjyoti Baishya
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam