A Randomized controlled clinical study to assess the effect Of Varunadi Vati in management of Medodushti with special reference to Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of “Varunadi Vati†on Lipid Levels (Lipid Profile) in Dyslipidemia.
研究概览
简要总结
The main aim of Ayurveda is to cure the diseases and maintain health state. Ayurveda aims in maintaining and restoring body’s own capacity to have balance and fight with ailments.
In today’s era, excessive intake of food along with stress, lack of exercise, and frequent consumption of junk food, canned food, soft drinks, beverages, food containing high amount of fat and calories leads to Coronary Artery Disease [1] making lipid disorders as one of the most common disorders of present era. In our body there are many tissues which are rich in lipids such as Medo Dhatu, Vasa and Majja Dhatu. Among the above lipids, Medo Dhatu is very important as it has a significant role in developing many metabolic diseases.[2]
Dyslipidemia involves abnormality in levels of any or all lipoproteins in the blood. It can be co-related to “Medodushti†as described in Ayurveda. [3]
High fatty diet (Snighdha, Guru, Pichhila) and sedentary lifestyle (Cheshtadvesha, Asana-sukha) may contribute to Dyslipidemia. This is described as “Medodushtiâ€. This condition is associated with several morbid manifestations. Dyslipidemia is highly prevalent and is one of the most modifiable risk factors for Cardiovascular disease. Worldwide, Cardiovascular disease is now one of the most common causes of death. [3]
High cholesterol levels are estimated to cause 18% of stroke, and 56% of Ischemic Heart Disease that accounted to 4.4 million deaths, annually worldwide. Rigorous support is provided by the prospective, community-based Framingham Heart study for the concept that Hypercholesterolemia and other factors correlated with Cardiovascular risk. (4)
Dyslipidemia is an elevation of Plasma Cholesterol, Triglycerides or both or a Low/ High Density Lipoprotein Level that contributes to the development of Atherosclerosis. For early development of Cardiovascular diseases; risk factors are Hypertension, Atherosclerosis, Dyslipidemia, Chronic inflammation etc. Cardiovascular diseases is a leading cause of mortality in many economically developed nations accounting near about 30% of all deaths. The co-existence of Hypertension and Dyslipidemia has adverse impact on vascular endothelium, which results in enhanced Atherogenesis leading to Cardiovascular and Cerebrovascular diseases. [3]
We can correlate Dyslipidemia with “Medodushtiâ€. According to Acharya Charaka, major/daily intake of causative factors aggravate Kapha Dosha and Meda Dhatu due to similar properties, thus increases Meda, which obstructs the Strotasas and hence obstructed Vata circulates in the Koshtha becomes hyperactive leads to Jatharagni Vruddhi.[6] Vruddha Jatharagni digests the food rapidly. If a person requires the food frequently or in high quantity, it increases Vata as well as Jatharagni on unavailability of food tends to severe complications. Jatharagni plays a very important role in growth, development and maintenance of the body. If it is impaired, the Bhutagni and Dhatvagnis (related to Liver and Cellular metabolism), especially impaired Medodhatvagni resulting in homologous nutrients i. e excess Poshak Meda Dhatu in circulation ultimately develops Dyslipidemia. The Ayurvedic methods of lifestyle modification and Apatarpanajanya Ahara prevent Dyslipidemia and provide better management over Allopathic drugs burden.
Prevalence of Dyslipidemia according to NCEP (National Cholesterol Education Programme) is very high with 79% of subjects having at least one lipid abnormality.[5]
In the first phase of ICMR INDIAB study [4] the prevalence was 13.9% in Hypercholesterolemia, 29.5% in high TG, 72.3% in low HDL-C and 11.8% in high LDL-C. According to Recent trends in epidemiology of Dyslipidemia in India (Indian Heart Journal 2017), total cholesterol ≥200 mg/dl was present in 25–30% in urban and 15–20% in rural subjects. The increase of Prevalence of Hypercholesterolemia and Hypertriglyceridemia is more prominent in 31-40 years age group than in ≤30 years age group.[4] The National Cholesterol Education Program Expert Panel (NCEP) on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) reinforced LDL as the Primary target of Cholesterol- lowering therapy with the optimal goal of its level below 100 mg/dL. ‘Statins’ are usually Recommended as they reduce LDL cholesterol by up to 60% and produce small increase in HDL and modest decrease in TGs. [4] Recent studies reported that high Cholesterol is present in 25-30 % in Urban & 15 -20% in Rural population. The most common Dyslipidemia in India are borderline for high LDL Cholesterol, Low HDL Cholesterol and Triglycerides. Studies have reported that over 20 years of period, Total Cholesterol, LDL and Triglycerides have increased among Urban population. [4]
The contents of “Varunadi Vati†are Varuna (Crataeva nurvala), Haritaki (Terminalia chebula) and (Purana & Shuddha) Guggulu. (Commiphora mukul), which are described in Ashtangsamgraha’s Vividhganasangraha Adhyaya of Sutrasthana. Katu Rasa of Varuna and Haritaki, as well as (Purana and Shuddha) Guggulu will increase the activities of Kleda-Shoshana and Lekhana with the help of their particular characteristics [7]. Because of Tikta Rasa of Varuna, Haritaki and (Purana and Shuddha)
Guggulu, this Kalpa can achieve Kledaharana, Medoshoshana, Deepana-Pachana and Kaphashamana [8] All this can be beneficial in Sampraptibhanga of “Medodushti†(Dyslipidemia). Additionally, ‘Predominant Katu Vipaka’ of Varuna and (Purana and Shuddha) Guggulu will play a role to reduce vitiated Kapha in the said disease with the action of ‘Laghu Guna’. The most important feature of this Guggulu Kalpa is ‘Rasayana quality’, so as to gain the resistance power against this disease by maintaining equilibrium of Tridoshas in the body as per ‘Rasayana Principle’. The most precious quality of (Purana and Shuddha) Guggulu is, it is the most ‘Shreshtha’ (Predominant) Dravya among Meda-Vataharadravyas. It also acts as Tridoshahara(9 ,10] and Lekhaniya Dravya[11] After observation of previous research on all above said properties of this Varunadi Vati, we can say that it will definitely lead to expected Sampraptibhanga (breaking of Pathophysiology) in “Medodushti†(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)(—)
入选标准
- •Inclusion Criteria – Both Genders.
- •Age group having 30 to 70 years age.
- •Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New Updated WHO classification of BMI of 2004).
- •Patient having Serum Total Cholesterol Level ≥200mg/dl Patient having Serum LDL Cholesterol Level ≥130mg/dl Patient having serum VLDL Cholesterol Level ≥40 mg/dl Patient having Serum HDL Cholesterol Level ≤40mg/dl Patient having Serum Triglyceride Level ≥150mg/dl.
排除标准
- •Exclusion Criteria- Pregnant and lactating mothers.
- •Patients having Diabetes Mellitus.
- •Patients having history of Respiratory Diseases Complications, Coronary Heart Diseases, Renal Diseases etc.
- •Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with age 60 and older, and 140/90 mm Hg for adults less than 60 yrs.
- •According to Eighth Joint National Committee Guideline), Hepatitis or with history of major surgery etc.
- •Patients having disorders like Carcinoma anywhere in the body etc.
结局指标
主要结局
To assess the effect of “Varunadi Vati†on Lipid Levels (Lipid Profile) in Dyslipidemia.
时间窗: 8 weeks | Follow up: Screening of patients clinically every week and Lipid Profile repeated every month (i.e every 4 weeks)
次要结局
- To observe the effect of ‘Varunadi Vati’ in comparison with Tab. Atorvastatin on Lipid Profile in patients of Dyslipidemia over a period of 8 weeks.
研究者
Akanksha Vijay Agale
R. A. Podar Medical College (Govt.) (Ayu)
