Original Papers Effectiveness, Safety, and Tolerability of Powdered Nigella sativa (Kalonji) Seed in Capsules on Serum Lipid Levels, Blood Sugar, Blood Pressure, and Body Weight in Adults: Results of a Randomized Double-Blind Controlled Trial Waris Qidwai, M.C.P.S., F.C.P.S., 1 Hasan Bin Hamza, M.Sc., 2 Riaz Qureshi, F.R.C.G.P. (UK), 3 and Anwar Gilani, Ph.D. 4 Abstract Objective: The seed extracts from Nigella sativa is used by Unani physicians of traditional medicine (Hakims or Tabibs) and Ayurvedic practitioners (Vaids) in the treatment of several medical disorders including dyslipidemia, obesity, and hypertension. It is, therefore, important to prove or disprove the effectiveness, safety, and tolera- bility of powdered N. sativa (Kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults. Design: The study design was a randomized, double-blind trial. Settings=location: Conducted at Aga Khan University Hospital, Karachi, from February 2006 to January 2007. Subjects: Half of the respondents received powdered N. sativa (Kalonji) seed in capsule and the rest received a placebo. Intervention= outcome: Baseline and after-intervention variables recorded were the following: body–mass index, waist–hip ratio, blood pressure, fasting blood sugar, serum lipids, serum alanine aminotransferase, and serum creatinine. Results: One hundred and twenty-three (123) patients were recruited. Sixty-four (64) and 59 patients were randomized to the intervention and the control arms, respectively. Thirty-nine (39) patients in the intervention group and 34 in the control group completed the study. Favorable impact of powdered N. sativa (Kalonji) seed in capsule was noted on almost all variable but results were not statistically significant, because of small sample size. Conclusions: Favorable impact of powdered N. sativa (Kalonji) seed in capsule was noted on almost all variables, but results were not statistically significant. A larger study with adequate sample size is recommended. Introduction P akistan is a developing country with limited resources and a high burden of diseases such as dyslipidemia, di- abetes mellitus, hypertension, and obesity. 1–3 Nigella sativa (black cumin) is a small plant originating in the Middle East and is found abundantly, growing wild in Egypt, Asiatic Turkey, and the Balkan states. N. sativa seeds are claimed to have bronchodilatory, hypotensive, antibacterial, antifungal, analgesic, anti-inflammatory and immunopotentiating prop- erties. 4,5 The seed extracts from this plant are used by Unani Physicians of Traditional Medicine (Hakims or Tabibs) and Ayurvedic Practitioners (Vaids) in the treatment of several medical disorders including dyslipidemia, obesity, and hy- pertension. Several studies have demonstrated the favorable impact of Nigella sativa seed extract on dyslipidemia in rats. 6 Evidence exists regarding cultivation and use of N. sativa seeds in Pakistan for its medicinal properties. 7 1–3 Department of Family Medicine, Aga Khan University, Karachi, Pakistan. 4 Department of Biological and Biomedical Sciences, Aga Khan University, Karachi, Pakistan. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 15, Number 5, 2009, pp. 1–6 ª Mary Ann Liebert, Inc. DOI: 10.1089=acm.2008.0367 1 ACM-2008-0367-Qidwai Type: research-article ACM-2008-0367-Qidwai.3D 03/21/09 11:44am Page 1