Therapeutic evaluation of Kalonji (Nigella sativa) in dyslipidemia - A randomized control trial

Dyslipidemia is one of the most common risk factors of cardiovascular diseases. An increased level of cholesterol is responsible for atherogenesis, which ultimately leads to the development of cardiovascular, cerebrovascular, and peripheral vascular diseases. According to a survey report, 36.3% patients are dyslipidemic; therefore, the problem is increasing day by day as a huge cause of morbidity and carries economic burden for society. These days, dyslipidemia is treated using lipid-lowering agents with lifestyle intervention; however, lipid-lowering agents produce various side effects. In Unani system of medicine, several drugs are used as lipid-lowering agents, which are comparatively safe. However, such drugs are still not validated on scientific parameters. Thus, a clinical trial was conducted with the objective to evaluate the efficacy and safety of Unani drugs in the management of dyslipidemia.
The study was designed as single-blind, randomized with standard control. Thirty patients of dyslipidemia were selected and randomly assigned to control and test groups, the test group comprising 20 patients and the control group comprising 10. The test group received the powder of Kalonji in the form of capsule (two capsules twice a day) and the control group received Lipotab(R) (two tablets once a day for 60 days). All the patients were assessed on subjective and objective parameters. The result was analyzed statistically using appropriate statistical tests.
The test drug shows significant results on few subjective and objective parameters in comparison to the control drug. Overall, improvement was observed in the test group without any clinically and statistically significant side effects or toxicity. The compliance to the treatment was found good.
The study revealed that the comparative analyses of both test and control drugs were not statistically significant, but improvements in subjective and objective parameters were present in both groups.