Ayurvedic formulation developed for the prevention and management of Metabolic syndrome and cardiovascular risk
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The impact of Ayurvedic formulation on body mass index, lipid profile, blood pressure, leptin and adiponectin level.
研究概览
简要总结
A randomized double blinded conventionalcontrolled clinical trial shall be carried out to validate the beneficial roleof novel poly-herbal formulation beneficial in the prevention of cardiovasculardisorders among metabolic syndrome patients. The age range of metabolicsyndrome will be 40-70 years of both the gender. The modern conventional agent Orlistat shall be used for controldesign. The biological potential of test formulation will be evaluated on theassociated markers with metabolic syndrome as described earlier. Minimum 1000patients of metabolic syndrome shall be included in the clinical trial and willbe followed up for a period of 1 year. The advanced statistical method will beapplied to establish the beneficial role of test formulation in the preventionand management of metabolic syndrome and associated cardiovascular riskfactors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Triglycerides>150 mg%
- •Abdominal girth Male > 102 cm and Female > 85 cm
- •HDL < 40 mg% in Male and < 50 mg% in Female
- •Fasting Blood Sugar > 100 mg%.
排除标准
- •FBS <100 mg%
- •TG <150 mg%
- •BP Systolic < 130 mmHg and Diastolic <85mmHg.
结局指标
主要结局
The impact of Ayurvedic formulation on body mass index, lipid profile, blood pressure, leptin and adiponectin level.
时间窗: A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment.
次要结局
- Modified atherogenic dyslipidemia along with improvement in feeling of well being and work performance was noticed.(A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment.)