A Randomized Controlled Clinical Study to assess the effect of Devadarvyadi Vati (Combination of Devadaru,Vacha,Nagara with Guggulu) in the management of Medodushti with special reference to Dyslipidemia.

In Sanskrit, Ayurveda means The Science Of Life.Ayurvedic Knowledge originated in India more than 5000 years ago,and is often called the Mother of Healing. Ayurveda goes beyond treating diseases and is a healthcare system teaching one how to be healthy(Svastha Rakshana) by facilitating harmonious diet (Ahara) and activities (Vihara). Dyslipidemia means Dys(disordered), Lipids(fat), Emia(in the blood) that is Disordered Lipids in the blood.We can corelate it with Medodushti.Dyslipidemia is characterized by a disorder of lipoprotein metabolism as a result of abnormal production of lipoprotein.This condition refers to alteration in Plasma Cholesterol mainly High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglyceride(TGL). Dyslipidemia is a condition wherein one or more variable levels are elevated like Total Cholesterol Level above 200 mg/dl or Triglyceride > 150mg/dl or High Density Lipoprotein <40mg/dl  or Low Density Lipoprotein >140 mg/dl. The new Dyslipidemia index is based on composite values of Total Cholesterol level above 200 mg/dl and its ratio with HDL>4.5. Dyslipidemia could be responsible for several morbid conditions like Obesity,Hypertension,Diabetes, Cardiovascular disorders and Metabolic Syndrome.

We can correlate Dyslipidemia with Medodushti. According to Ayurveda a person having Avyayama,Achinta,Diwaswapna,Atisnigdha,Atimatara Ahara and Beeja Swabhava leads to Medovaha Srotodushti. Kapha Dosha vitiation takes place in an individual who indulges in frequent consumption of Shleshmala diet(Madhura,Guru,Sheeta) without undertaking adequate physical activity and rather sleeps for a long time. The above mentioned etiological factors leads to disturbance in Jatharagni consequently in Dhatvagni and Bhutagni, which results in Agnimandya, leading to production of Ama. It further disturbs the production of Saptadhatus. Hence derangement of Jatharagni in general and Medodhatvagnimandya in particular hampers its capacity to digest Medamsa,ultimately leading to the formation of Saama Medo Dhatu thereby causing Medodushti (Dyslipidemia).

Prevalence of Dyslipidemia:

According to NCEP (National Cholesterol Education Programme) Dyslipidemia is very high with 79% of subjects having atleast one lipid abnormality. In the first phase of ICMR INDIAB study the prevalance 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 Epidemology 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.

The contents of Devadarvyadi Vati are Devadaru, Vacha, Nagara and Guggulu. Overall, the combination of Deavadaru, Vacha, Nagara and Guggulu will act by Tikta and/or Katu and /or Kashaya Rasas,Ushna Virya,Katu Vipaka with Laghu Guna creating Sneha/Meda/Vasa and Kleda Upashoshana with Lekhana ultimately to correct Dyslipidemia. Aditionally Guggulu will develop immunity against the said disease as being Rasayana Dravya. After observation of previous research on all above said properties of this Devadarvyadi Vati,we can say that it will definitely lead to expected Sampraptibhanga(breaking of Pathophysiology) in Medodushti (Dyslipidemia).

Rationale of Study:

India is middle of Atherosclerotic Cardio Vascular Disease (ASCVD) which shows no signs of abating.Coronary artery disease manifest almost a decade earlier in India than in western countries.Further incidence of CAD increasingly rapidly among patients younger than 40yrs of age.About 10-25% of MI(Myocardial Infarction) in India occurs before age of 40 years & more than 50% of CAD assosciated deaths in India occurs before the age of 40 years,so the optimal management of Dyslipidemia is key to stem the epidemic of ASVCD along with control of risk factors.Dyslipidemia is a major risk factor for Cardiovascular Disease,the leading cause of death. According to World Health Organisation(WHO) the prevalence of Cardiovascular Diseases will be double by 2020 and will rank before the HIV/AIDS infection.Currently available Hypolipidemic drugs (statins) are either expensive or often related with side-effects like Dyspepsia,Headache,Myopathy,Myalgia, Abdominal Pain etc. Hence,there has been pursuit for new safe and effective drug for Dyslipidemia. Hence, it is a necessity to find out some human health friendly and cost wise cheap formulations to eradicate this disease.

Number of Patients:

Group A (Trial Group) -32 patients

Treatment: Devadarvyadi Vati will be given twice a day before food (Pragbhakta)

Group B (Control Group) - 32 patients

**Treatment:**Tab Atorvastatin 10 mg will be given at bed time.

Investigations:

1. CBC,ESR,Liver Function and Renal Function Tests before treatment as a routine and to exclude complications said in Exclusion Criteria.

2. Blood Sugar (Fasting and Post-Prandinal) before treatment as routine and to avoid Diabetes Mellitus.

3)Lipid Profile before and after treatment (to be repeated after 4th week and 8th week).

4)X-ray Chest (PA View) before treatment as routine to avoid Respiratory Diseases Complications.

5. ECG before treatment as routine to avoid Cardiac Diseases Complications.

Summary and Conclusion:

Clinical Study Work will be summarized with Observation of Results and Statistical Analysis under the heading Conclusion by discussion and explanation will be given at the end of whole research.

Expected Outcome:

1)Changes in Lipid Profile by Deavadarvyadi vati (Combination of Devadaru,Vacha,Nagara with Guggulu) towards reduction in previous high levels.

2)Effect of Devadarvyadi Vati (Combination of Devadaru,Vacha,Nagara with Guggulu) may be more than the effect of Tab Atorvastatin without any adverse effects.