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 allopathy-related hypolipidemic agent Fenofibrate, we conducted this research. It was single blind placebo-controlled 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 five patients of group-A were advised to take two grams of Kalonji, twice daily. Twenty five patients of group-B were advised to take Fenofibrate 40 mg tablets, BD ie; one after breakfast and one after dinner. Twenty five 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 significance as the difference. A probability value of <0.05 was considered as non-significancant and P<0.001 was considered as highly significant 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 LDL-cholesterol highly significantly. HDL-cholesterol was increased in this group significantly with p-value <0.01. Fenofibrate decreased TC, TG, and LDL-cholesterol highly significantly with p-value <0.001, while increase in HDL-cholesterol was significant 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 specific time.