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.
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 tolerability of powdered N. sativa (Kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults.


METHODS
The study design was a randomized, double-blind trial.


METHODS
Conducted at Aga Khan University Hospital, Karachi, from February 2006 to January 2007.


METHODS
Half of the respondents received powdered N. sativa (Kalonji) seed in capsule and the rest received a placebo.


RESULTS
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 variables, 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.
Qidwai
Waris
W
1 Department of Family Medicine, Aga Khan University, Stadium RoadP.O. Box 3500, Karachi 74800, Pakistan. waris.qidwai@aku.edu
Hamza
Hasan Bin
HB
Qureshi
Riaz
R
Gilani
Anwar
A
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001786:Blood Glucose; D001794:Blood Pressure / Q000187:drug effects*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D031881:Nigella sativa; D009765:Obesity / Q000097:blood / Q000188:drug therapy; D008517:Phytotherapy; D010865:Pilot Projects; D010919:Placebos; D028321:Plant Preparations / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D012639:Seeds; D049629:Waist-Hip Ratio
D001786:Blood Glucose; D008055:Lipids; D010919:Placebos; D028321:Plant Preparations; D003404:Creatinine; D000410:Alanine Transaminase