Black Seed Oil in Treatment of Osteoarthritis

NCT06029868 | Completed DMC

• 1 other identifier: IR.BUMS. REC.1398.020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (3)

• Knee joint pain

  Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) .reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain)

  48 days

• joint movement limitation

  Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).

  48 days

• joint dryness

  Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation)

  48 days

Study Arms (2)

Black seed

EXPERIMENTAL

Black seed oil capsule taken orally

Dietary Supplement: Black seed oil capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule taken orally

Dietary Supplement: Placebo Black seed oil capsule

Interventions

Black seed oil capsule DIETARY_SUPPLEMENT

700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company,

Black seed

Placebo Black seed oil capsule DIETARY_SUPPLEMENT

Placebo Black seed oil capsule

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral or bilateral involvement of one or more joints for over 4 months,
• ability to walk
• ability to stay throughout the study period
• no history of underlying inflammatory disease (arthropathy / rheumatoid arthritis),
• absence of diabetes,
• no history of allergy to black seed
• absence of hyperuricemia (\<338 umol/l) or history of gout,
• absence of recent injury and trauma to the joint with osteoarthritis,
• absence of intra articular injection of corticosteroids in the last 4 months,
• lack of sensitivity to NSAIDS,
• no underlying liver and kidney disease or history of peptic ulcer Or gastrointestinal bleeding, Congestive Heart Failure, hypertension, and hyperkalemia ,
• no fever
• absence of obvious Complete Blood Count disorders, coagulopathy, hematologic or neurological disorders ,
• no alcohol consumption

You may not qualify if:

• pregnancy,
• breast feeding,
• pregnancy-related decision
• obesity (BMI\> 30 kg /m2).

Sponsors & Collaborators

• Ramsar international campus: lead

Study Sites (1)

Ramsar international campus

Ramsar, Mazandaran, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammad khodashenas roudsari ,Assistant prof of internal medicine

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: January 14, 2019
• Primary Completion: June 20, 2019
• Study Completion: February 12, 2020
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)