A Randomized, Standard Controlled, Clinical Study to Evaluate the Safety and Efficacy of Jawᾱrish Falafili in the Treatment of Farṭ-e- Tadassum fi’l Dam (Dyslipidaemia)

Dyslipidemia, synonymous with Hyperlipidemia orHyperlipoproteinemia, defined as a disorder of lipoprotein metabolism,including lipoprotein overproduction or deficiency and manifested by elevationof the total cholesterol, the low-density lipoprotein (LDL) and thetriglyceride concentrations, and a decrease in high-density lipoprotein (HDL)concentration in the blood. [1]

Dyslipidemiais co-related with *Siman MufritÌ£*in Unani system ofmedicine in clinical features and complications. Prolonged dyslipidemia may lead to Atherosclerosis, Ischaemic Heart Disease,Hypertension, Stroke, Nephropathy, Retinopathy, Diabetes, Obesity, Fatty liver.[2]Ischemic HeartDisease (8.92 million deaths per year) is the main cause of death all over theworld Worldwide one-third of Ischemic heart disease is due todyslipidemia. In 2008 the global prevalence of raised total cholesterol levelamong adults (>5.0 mmol/l) was 39% (37%for males and 40% for females). [4]

Increase level of atherogenic lipoprotein especially LDL,IDL, lipoprotein(a) and chylomicron remnants contribute to the pathogenesis ofAtherosclerosis and these are the most modifiable risk factor for Coronaryartery disease. [5] According to the WHO World Health Statistics Report,globally one in six adults are obese and nearly 2.8 million individuals dieeach year due to overweight or obesity. [6] Dyslipidemia is one of the major factorconstituting to Metabolic syndrome which is defined by a constellation of aninterconnected physiological, biochemical, clinical, and metabolic factors thatdirectly increases the risk of atherosclerotic cardiovascular disease. [7,8] This includesAtherogenic dyslipidemia, glucose intolerance, hypertension, proinflammatorystate, and a prothrombotic state. Raised level of cholesterol increases therisk of heart disease and stroke.

Dietary management along with hypolipidemic drugs is themainstay of treatment in conventional system of medicine, which include HMG-CoAreductase inhibitors (Statins- Atorvastatin, Simvastatin), Bile acid sequestrants(Resins- Cholestyramine, Colestipol), Lipoprotein lipase activators(PPARα activators, Fibrates- Clofibrate, Gemfibrozil), Lipolysis andtriglyceride synthesis inhibitor (Nicotinic acid), Highly polyunsaturated longchain-3 Fatty acids but all of these have some side effects includingconstipation, exacerbation of hemorrhoids, nausea, increased bleeding relatedto vitamin-K malabsorption, Vitamin-A and D deficiencies. [9] Adverseeffects associated with Statins are Cognitive loss, Neuropathy, Rhabdomyolysis,myositis, myalgia, pancreatic and hepatic dysfunction, increased the incidenceof diabetes, sexual dysfunction. [10]

Highprevalence of disease, life-threatening complications, and complications ofconventional medicine warrants search of treatment which should be safe,efficacious, cost-effective and easily available to alleviate such a complexdisease of serious complications. In Unani system of medicine, the drug whichhas Hot and Dry temperament and contains the property of TahÌ£liÌ„l(resolvent), TajfiÌ„f(Desiccant), TehziÌ„l(Emaciating), Mudirr(Diuretic)properties used in the treatment of obesity. [11,12,13]

Keepingin mind all of the above points and drawbacks of modern medicine, there is aneed to search an effective medicine to treat dyslipidemia. After a review ofthe literature, a pharmacopoeial compound formulation JawaÌ„rishFalafilihaving an indication for *Siman MufritÌ£*hasbeen selected for this study. [13,14,15] The drug constituting thisformulation having the hot and dry temperament and possesses MulatÌ£tÌ£if(Demulcent), MufattihÌ£(Deobstruent), MohÌ£allil(Resolvent), Qat-e-balgham, HazÌ£im(digestive), Mudirr-e-boul(Diuretic)properties. Some of the drugs in this formulation have been evaluated as ananti-hyperlipidemic effect. [16,17,18] A Preclinical study has alreadybeen conducted on JawaÌ„rish falafilias Anti- hyperlipidemicby Nazia et al. which shows significant results. So, the present study isdesigned to evaluate the efficacy and safety of JawaÌ„rishfalafiliin Dyslipidemia.