To study the efficacy of Varasanadi kashaya in comparison with Guduchibadhramustadi kashaya in Dyslipidemia: A controlled randomized clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in the lipid profile.
研究概览
简要总结
A Controlled Clinical Study on the Efficacy of Varasanadi Kashaya in the Management of Dyslipidemia in adults of age group of 20-60 years for a period of 30days. During this study period, 30 subjects diagnosed with Dyslipidemia will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group), 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Varasanadi Kashaya (50ml BID Before food) for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 30th day and after trial on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Guduchibadhramustadi Kashaya (50ml BID Before food) for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 30th day and after trial on 45th day. Clinical assessment will be done for both subjective and objective criteria on 0th day, 30th day and after trial 45th day. Statistical analysis will be done through data obtained on before and after treatment assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with age group of 20-60 years of either sex irrespective of religion will be selected.
- •2.Subjects fulfilling all or at least any one of the diagnostic criteria.
- •3.Fresh cases and patients on medication of dyslipidemia maintaining the manufacturer and batch compulsorily with persisting signs and symptoms and altered quality of life.
排除标准
- •1.Subjects belonging to the age group of below 20 and above 60 years.
- •2.Subjects suffering from Chronic systemic illness like Type 1 DM, uncontrolled Type 2 DM, uncontrolled Hypertension.
- •3.Pregnant and lactating women.
- •4.Subjects under corticosteroid medications.
- •5.Subjects having history of myocardial infarction, stroke.
- •6.Subjects suffering from pancreatitis, thyroid dysfunction.
结局指标
主要结局
Improvement in the lipid profile.
时间窗: 0th day(Baseline), 30th day and 45th day
次要结局
- Improvement in the lakshana of Medo roga.(0th day(Baseline), 30th day and 45th day)
研究者
Dr Deepika S
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru.