Single blind placebo-controlled study on hypolipidemic potential of drugs

Complications associated with high serum cholesterol levels include hypertension, CCF, cardiac arrhythmias, and cardiac arrest. To compare hypolipidemic potential of herb nigella sativa with allopathyrelated hypolipidemic agent Fenofi brate, we conducted this research. It was single blind placebocontrolled study conducted at Ghurki trust teaching hospital, Lahore from February 2017 to July 2017. 75 diagnosed secondary hyperlipidemic patients were selected with age range from 20 to 70 years. Patients suffering from hypothyroidism, diabetes mellitus, any gastrointestinal upset, renal impairment, and any hepatic or cardiac disease. Grouping: All patients were divided in three groups (group-A, group-B, group-C), 25 in each group. The study period was eight weeks. Twenty fi ve patients of group-A were advised to take two grams of Kalonji, twice daily. Twenty fi ve patients of group-B were advised to take Fenofi brate 40 mg tablets, BD ie; one after breakfast and one after dinner. Twenty fi ve patients were provided placebo capsules, (containing grinded sorghum), taking one capsule after breakfast and another before going to bed. All participants were advised to take these medicines for eight weeks. Method: Serum LDL-cholesterol was calculated by Friedwald formula1 (LDL-Cholesterol = Total Cholesterol-(Triglycerides/5 +HDL-Cholesterol). Data were expressed as the mean ± SD and “t” test was applied to determine statistical signifi cance as the difference. A probability value of <0.05 was considered as non-signifi cancant and P<0.001 was considered as highly signifi cant change in the results when pre and post-treatment values were compared. After 8 weeks when results were compiled and analyzed statistically, it was observed that Kalonji reduced total cholesterol (TC), triglycerides (TG), and LDLcholesterol highly signifi cantly. HDL-cholesterol was increased in this group signifi cantly with p-value <0.01. Fenofi brate decreased TC, TG, and LDL-cholesterol highly signifi cantly with p-value <0.001, while increase in HDL-cholesterol was signifi cant with p-value <0.01. Conclusion: It was concluded from this study that hypolipidemic potential of herbal medication NIGELLA SATIVA is comparably same as hypolipidemic potential of allopathy related drug FENOFIBRATE when given in large amount (ie; 4 grams daily) for specifi c time. Research Article Single blind placebo-controlled study on hypolipidemic potential of drugs Akbar Khan Niazi1, A Shafi que2, Nusratullah Khan3, E Fatima4, Abdul Ghaffar5, S Murad6*, Azmat Ali7, Moosa Khan8 and Hafi z Moeen ud Din9 1Chairman IMDC & ANTH, Islamabad-Pakistan 2Consultant Pharmacist at MCC Pharmacy, Islamabad-Pakistan 3AP Biochemistry, at BMC, Pakistan 4Associate Professor of Pharmacology at LMDC, Pakistan 5CWO, IMDC, Pakistan 6IMDC and Akbar Niazi Teaching Hospital, Islamabad 7AP Pharmacology at Nafees Medical College, Pakistan 8Chairman at SZABMU, Pakistan 9AP Anatomy at AIMC, Pakistan Received: 26 September, 2018 Accepted: 16 October, 2018 Published: 18 October, 2018 *Corresponding author: Shah Murad, Professor at IMDC and ANTH, Islamabad, Pakistan, E-mail: https://www.peertechz.com


Introduction
Hyperlipidemia (also known as high cholesterol) refers to several disorders that can result in too much fat (lipids) in the blood. These lipids can enter the walls of the arteries and increase the risk for developing hardening of the arteries, which could cause heart disease or stroke. Hyperlipidemia can be controlled with lifestyle changes and medication. Baptist Health is known for advanced, superior care for patients with heart conditions and the diagnosis, treatment and management of hyperlipidemia. You will appreciate timely appointments and a professional, friendly atmosphere where we take time to listen to your concerns. At Baptist Health, you have access to the region's most comprehensive, multidisciplinary team of specialists and innovative therapies, including many available only through specialized clinical trials. In every way, we work to demonstrate the utmost in excellent care to those who trust us with their health. Hyperlipidemia is an umbrella term for those conditions characterized by an excessive amount of fats or lipids in the blood. From the practical point of view, for most patients hyperlipidemia is just the medical term for high cholesterol [1]. Conventional medicine has long advocated: high cholesterol causes heart disease -which represents the biggest killer in advanced countries. This has given rise to an entire industry of low-fat food products as well as cholesterollowering drugs, which are among the most widely prescribed medicines in the entire world! Unfortunately for this businesses, the connection is controversial at its best -and at worst, there's no connection at all! In fact, in biological medicine we see both: the problem and the solution differently! Hyperlipidemia is Dev Res 4(1): 020-023. DOI: http://doi.org/10.17352/ijpsdr.000018 essentially a disturbance of the body's ability to metabolize fats. Conventional medicine describes the condition as an epidemic and thus an alarming danger for today's society, and prescribes for almost every sufferer a category of drugs known as statins, which are now routinely given to men in the USA as a preventative measure -we have to know: they don't even have high cholesterol! Free radicle formation in human body is normal, but there are chances of development of atherosclerotic plaques if these free radicles are interacted with high plasma lipids [2]. Atherosclerotic plaques are stuck with endothelial layer of coronary arteries leading to development of coronary artery disease (CAD) [3]. Hypertension, congestive cardiac failure (CCF), cardiac arrest, and cardiac arrhythmia are consequences of CAD [4].One of the factors causing CAD is abnormal plasma lipid levels [5]. For prevention of CAD, either blood lipids must be at normal levels (by administration of hypolipidemic drugs) or free radicle formation must be reduced (by use of antioxidant medications) [6]. In allopathy niacin, statins, fi brates and psyllium are used as hypolipidemic agents.
Vitamin C, vitamin E, adenosine, lactoferrin and carotenoids are used as antioxidant drugs, which also reduce risk for developing CAD [7]. It is well known and established fact that Fenofi brate causes activation of peroxisome proliferator activated receptor  (PPAR), leading to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III, which inhibits lipoprotein lipase [8]. This phenomenon will ultimately reduce formation of TG, and VLDL. Nigella sativa or Kalonji is being used as medicinal herb since pre-historical times. It contains carvacrol, nigellicine, polyunsaturated fatty acids, alphahederin, thymoquinone, mucilage, sterols, and migellamine [9]. Kalonji affects HMG-Co-A reductase leading to decreased formation of cholesterol in hepatocytes. This herb contain thymoquinone which inhibits lipid peroxidation in liposomes [10,11]. Alphahederin, thymoquinone, mucilage, sterols, and migellamine present in kalonji scavenge superoxide anion and hydroxyl radicles leading to decreased chances of LDL oxidation, and development of coronary artery disease [10][11][12].

Type of study
The research work was single blind placebo-controlled, conducted at Ghurki trust teaching Hospital, Lahore from designed Performa, at start of taking medicine, like lipid profi le, blood pressure and pulse rate. The study period was eight weeks. Twenty fi ve patients of group-A were advised to take two grams of Kalonji, twice daily. Twenty fi ve patients of group-B were advised to take Fenofi brate 40 mg tablets, BD ie; one after breakfast and one after dinner. Twenty fi ve patients were provided placebo capsules, (containing grinded sorghum), taking one capsule after breakfast and another before going to bed. All participants were advised to take these medicines for eight weeks. They were also advised for 20 minutes brisk walk at morning or evening time. Patients were called every 2 weeks for follow up to check blood pressure, weight, pulse rate etc. Drug compliance to the regimen was monitored by interview and counseling at each clinical visits.
Biostatistical Analysis: Data were expressed as the mean ± SD and "t" test was applied to determine statistical signifi cance as the difference. A probability value of <0.05 was considered as non-signifi cancant and P<0.001 was considered as highly signifi cant change in the results when pre and post-treatment values were compared.

Results
When results were compiled and statistically analyzed by using SPSS, it was observed that Nigella sativa and fenofi brate decreased total-cholesterol, LDL-cholesterol, triglycerides highly signifi cantly (p-value <0.001) and increased HDLcholesterol signifi cantly (p-value <0.01) as compared to placebo treatment. Results are summarized as: Effects of KALONJI on lipid profi le of 25 hyperlipidemic patients: TC at day-0 was 231.21±1. 12

Discussion
If hyperlipidemia is suspected, we perform a physical examination and ask questions about symptoms. We then use advanced diagnostic procedures and technology to effectively diagnose, inform treatment and carefully monitor the condition.