Comparative study to evaluate the efficacy of Arjuna Kwath and Arogyavardhini vati in management of Medoroga (Dyslipidemia) A Randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Reduction in the hematological parameters of dyslipidemia
研究概览
简要总结
Dyslipidemia is one of the major escalating public health challenge worldwide, arising as a result of combination of some genetic factors and more importantly certain environmental factors like sedentary lifestyle, increased urbanization, nutritional advancement accompanying economic development, substance abuse and other associated medical conditions. According to Acharya Sushruta, when there is excess deposition of Medadhatu in body it may produce excessive greasiness in the body which results in a very bad smell, enlargement of abdomen and flanks (pendular hanging), cough, breathlessness are some other symptoms. Samprapti of is Medoroga is when accumulated Meda dhatu blocks Strotasa’s other Dhatu’s are not properly nourished as a result Meda Dhatu further gets increased. The person with Medo Roga will have Kshudra Shwas (breathlessness), Trishna (excessive thirst), Moha, Swapna (excessive sleep), Krathana (Sudden obstruction of breath), Sadana (looseness of the body) Kshuta (Excessive hunger) ,Sweda (excessive sweating), Daurgandhya(foul body smell), Alpa prana( Fatigue), Alpa Maithuna ( loss of libido) The prevalence of Dyslipidemia varies around the world depending on the age and ethnicity of population studied. In general, its prevalence increases with age. Though it affects both the gender but studies have shown that males are more predisposed than females. The Indian council of medical research Sevillians project reported a prevalence of Dyslipidemia of 37.5% amongst adults aged between 15-64 years.
The present study aims to evaluate the role of Arjuna kwath and Arogyavardhini vati in management of dyslipidemia.
Total number of patients are 62,31 in each group.
In group A- Arjuna kwath will be administered at a dose of 40 ml BD with lukewarm water empty stomach in early morning and evening. In group B- Arogyavardhini vati will be administered at a dose of 500 mg BD with lukewarm water empty stomach in early morning and evening. The design of study is a single centered open-labelled, Randomized, comparative, interventional study
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
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Diagnosed and confirmed cases of dyslipidemia based on investigation 2 Patients with any one or more Lakshana of Medoroga 3 Patient above 21 and below 60 years of age either sex who will fulfil the criteria of diagnosis 4 Patients willing and able to participate for trial 5 Patients having controlled Diabetes and Hypertension 6 Patients who are ready to give consent with firm home address and contact number which is readily accessible during course of trial.
排除标准
- •1 Patient not willing for trail 2 Patient with total cholesterol more than 400mg/dl or triglyceride more than 300mg/dl or LDL more than 200mg/dl or HDL less than 20mg/dl 3 Patient with Hypertension more than 160/100 mm hg 4 Patient having illness like uncontrolled Diabetes mellitus tuberculosis carcinoma or major illness like liver and renal disorders 5 Patient having past history of Myocardial infarction unstable angina and congestive cardiac failure 6 Patient below 21 years of age and above 60 yrs of age 7 Patient having hypersensitivity to any trail drug and their ingredients 8 Pregnant females and lactating mothers.
结局指标
主要结局
Reduction in the hematological parameters of dyslipidemia
时间窗: 75 days
Total serum cholesterol less than 200mg/dl
时间窗: 75 days
Serum Triglycerides less than 150mg/dl
时间窗: 75 days
LDL cholesterol level below 100 mg/dl
时间窗: 75 days
HDL cholesterol level above 40mg/dl in men and above 50mg/dl in women
时间窗: 75 days
VLDL cholesterol level below 30 mg/dl
时间窗: 75 days
次要结局
- Improvement in symptoms of Medoroga(1 Kshudra Shwasa-Breathlessness)
研究者
Dr Neha Tyagi
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi