Black Seed Oil in Treatment of Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella
      sativa oil in comparison with placebo on the reduction of osteoarthritis pain.

      This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr
      Hospital in 2019, in Birjand, on patients with mild osteoarthritis. The Western Ontario and
      McMaster Universities Osteoarthritis Index is applied to score the functional status of
      participants' joints.
    

Detailed description: 
      This study was a randomized controlled trial. Regarding to the inclusion criteria, 110
      osteoarthritis patients were included in this study based on clinical signs, physical
      examination and radiological signs. In the next step, a fully explanation was given to the
      participants around the conditions of conducting the research, and then the informed consent
      were collected. Subsequently, patients were randomly divided into two groups of recipients;
      black seed soft gel capsules (intervention) and placebo equally in accordance with
      demographic information. Furthermore, the two groups were randomly classified regarding to
      age, consequently the study population was divided into subgroups of categorized ages.
      Thereafter, an equal number of each subgroup was randomly selected and divided into two
      groups to take black seed and placebo. Therefore, the two groups were similar, but the exact
      membership of individuals in the groups were random. Due to the higher prevalence of
      osteoarthritis among women in the community, the number of female cases were higher. It
      should be noted that the experimenters as well as patients did not know who was receiving a
      particular treatment (Double-blinded study). Prior to commencing the study, participants were
      asked to take a regular 48-day course of anti-inflammatory therapy. The cases in the
      intervention group took 700 mg of black seed soft gel capsule once a day from Gorgan
      Essential Oil Pharmaceutical Company, and the control group were treated by placebo capsules
      in the same-color and shape of the drug, with a taste of rice bran. Moreover, questionnaires
      were filled to record demographic information of both groups including age, sex, history
      medication and diet. The condition of participants were evaluated twice before the treatment
      and 48 days after the onset of black seed. At the end of each period, joint pain scores, the
      range of activity, and the dryness of the joints of all patients were assessed, and their
      mean were measured.

      Data collection tools:

      Scoring the functional status of individuals' joints were evaluated by applying Western
      Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2]. The WOMAC questionnaire
      was published in the 1908s to assess osteoarthritis of hip and knee, which is a standard
      criterion for assessing the health status of patients' self-reported activity. Three criteria
      should be measured ranging between zero to 4 for each question, by the end of each evaluation
      period: reduce pain is identified based on the mean for the first 5 WOMAC questions (from no
      pain to severe pain), the 6th and 7th questions were specified for joint dryness (from no
      dryness to severe limitation),and Joint movement is determined based on the average of
      questions 0 to 24 (from no problem to severe limit).
    

Intervention name(s): Black seed oil capsule; Placebo Black seed oil capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company,; Placebo Black seed oil capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment