Efficacy of Trayushanadi lauha and Amrutadya guggulu in the management of Dyslipidemia- A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The present study is an open label double arm randomized comparative clinical trial designed to evaluate the efficacy of Trayushanadi Lauha and Amrutadya Guggulu in the management of Dyslipidemia which is correlated with Medoroga in Ayurveda Dyslipidemia is a major modifiable risk factor for cardiovascular diseases and is increasingly prevalent in both urban and rural populations In Ayurvedic parlance Medoroga arises due to Medovrddhi and Srotorodha leading to impaired nourishment of other Dhatus and manifestation of systemic symptoms A total of 40 subjects diagnosed with dyslipidemia as per National Cholesterol Education Program NCEP guidelines and classical features of Medoroga aged between 30 and 70 years will be randomly allocated into two groups of 20 each Group I intervention group will receive Trayushanadi Lauha 500 mg two tablets twice daily before food with warm water while Group II control group will receive Amrutadya Guggulu 500 mg two tablets twice daily before food with warm water The duration of treatment will be 30 days Assessment will be carried out before and after treatment using lipid profile parameters such as Total Cholesterol LDL C HDL C and Triglycerides as primary outcome measures Secondary outcome measures include assessment of clinical symptoms of Medoroga and evaluation of quality of life using the SF 36 questionnaire Safety will be monitored by recording any adverse drug reactions during the study period Statistical analysis will be performed using repeated measures ANOVA and one way ANOVA for primary outcomes while Friedman test and Kruskal Wallis test will be applied for secondary outcomes The study aims to compare and establish the relative efficacy of Trayushanadi Lauha and Amrutadya Guggulu and to provide scientific evidence for effective safe and economical Ayurvedic management of dyslipidemia
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
- 30.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patients diagnosed to have dyslipidemia as per the diagnostic criteria 2 Patients between age group 30 to 70 years 3 Patients belonging to either gender irrespective of socioeconomic status and caste 4 Subjects willing to participate in the study and ready to sign informed consent form.
排除标准
- •1 Patients who have received anti dyslipidemic medication within last 8 weeks 2 Known cases of dyslipidemia due to endocrine pathologies renal pathologies 3 Dyslipidemia due to drugs eg glucocorticoids 4 Known cases of uncontrolled hypertension diabetes mellitus 5 Known cases of impaired hepatic and cardiac function 6 Pregnant women 7 Lactating mothers.
研究者
Dr B L Sampritha
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
