A randomized controlled clinical trial to study the effect of Ayurvedic management with Daruharidra churna and Aarogyavardhini vati on Medoroga with special reference to Dyslipidemia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in signs and symptoms of Medoroga after ingestion of Daruharidra churna and Aarogyavardhini vati
研究概览
简要总结
medoroga is defined as a disease , characterized by excessive body fat. On the basis of the symptomatology, Medoroga can be correlated with Dyslipidemia. Dyslipidemia is abnormally elevated levels of any or all lipids or lipoprotein in the blood,associated with other manifestations.The prevalence of Dyslipidemia in India is 15%. Daruharidra churna which have Tikta, Kashay rasa,Katuvipak and ushnavirya and gunas like laghu-Ruksha which are helpful to breakdown pathophysiology of Medoroga.The wood extract of the plant, with chemical constituents such asproto-berberine, isoquinoline, bisbenzyl-isoquinoline, flavonoids and phenolic acid and Aarogyavardhini vati effectively removes excess fat, eliminates toxins, and reduces cholesterol levels in the body which revealed that the study had a vital role in the management of Dyslipidemia. The patients within the age group of 18-60 years who fulfills the clinical diagnostic criteria for Dyslipidemia & having symptoms of Medoroga as mentioned in classics are selected irrespective of sex, socio-economic status, and community, written consent from patient will be taken prior to study. Computerised generated Sampling technique will be used. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group). Daruharidra churna & aarogyavardhini vati Group A (trial group) with dose 5gm BD for 1st 3 wks and 500mg BD for next 4 wks & anupanan koshna jal and Arjuna churna & aarogyavardhini vati Group B(Control group) with dose 5gm BD for 1st 3 wks and 500mg BD for next 4 wks & anupana koshana jal will be given to patients. Both drugs will be administered in churna & vati form for 7 weeks. Observations will be done on 0 Day,3rd week,7th week. Result of study will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patient having age between 18 years to 60 years and irrespective of socioeconomic status, sex and religion.
- •Newly diagnosed Dyslipidemic patients
- •Patient associated with hypertension
- •Patient having Serum Total Cholesterol Level more than or equal to 200mg/dl
- •Patient having Serum Triglyceride Level more than or equal to 150mg/dl
- •Patient having LDL Cholesterol more than or equal to 100 mg/dl
- •Patient having HDL Cholesterol less than or equal to 40 mg/dl .
排除标准
- •The patient having Cardiovascular disease, pulmonary, renal and hepatic disease etc.
- •pregnant women
- •DYSLIPIDEMIA due to drugs e.g. Anticonvulsant, Beta blockers,Corticosteroid etc
- •Patient having history of metabolic disorders and Endocrine diseases such as Diabetes mellitus ,etc.
结局指标
主要结局
Reduction in signs and symptoms of Medoroga after ingestion of Daruharidra churna and Aarogyavardhini vati
时间窗: 7 weeks
次要结局
- Where the trial group stands in comparison with control group(18 Months)