title: Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.
abstract: OBJECTIVE
  Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions.
  
  
  METHODS
  We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis.
  
  
  RESULTS
  Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences.
  
  
  CONCLUSIONS
  It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis.
authors.affiliation: Rheumatology Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Salimzadeh
authors.affiliation: Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Anahita
authors.initials: A
authors.lastname: Ghourchian
authors.affiliation: Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Rasool
authors.initials: R
authors.lastname: Choopani
authors.affiliation: Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Homa
authors.initials: H
authors.lastname: Hajimehdipoor
authors.affiliation: Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Kamalinejad
authors.affiliation: Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Abolhasani
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000302:isolation & purification; D001696:Biomechanical Phenomena; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007492:Iran; D007719:Knee Joint / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008519:Medicine, Traditional; D008875:Middle Aged; D031881:Nigella sativa / Q000737:chemistry; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D010602:Pharmacopoeias as Topic; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects / Q000302:isolation & purification; D010946:Plants, Medicinal; D011446:Prospective Studies; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D018501:Antirheumatic Agents; D010936:Plant Extracts; D000082:Acetaminophen
keywords: Iranian traditional medicine; Knee injury and Osteoarthritis Outcome Score; Nigella sativa L.; Osteoarthritis; randomized clinical trial