None listed
Conditions
Brief summary
The purpose of this study is to investigate the preliminary effectiveness and safety of a topical cannabidiol salve for rheumatoid arthritis. We hypothesise that using the salve for 4 weeks will have a clinically significant effect on functional status. This is an open label trial with all participants receiving the intervention for 4 weeks. Participants will apply the salve to affected joints twice daily for 28 days. The primary outcome is change in functional status. Secondary outcomes include health-related quality of life, pain, swollen and tender joint count, side effects, and change in inflammation.
Interventions
Topical cannabidiol (OMG Unwind 2600mg Salve) containing 100% CBD isolate as the Active Pharmaceutical Ingredient (API) with a broad range of excipients. (Total cannabinoid content is 2600mg of CBD in 56g tube. 46mg/g), applied to affected joints twice a day for 28 days. There is no prescribed amount to be administered each time as the instructions are to roll the salve on in a circular motion in the affected area and then gently rub in. There is no minimum time for the salve to remain on affec
Topical cannabidiol (OMG Unwind 2600mg Salve) containing 100% CBD isolate as the Active Pharmaceutical Ingredient (API) with a broad range of excipients. (Total cannabinoid content is 2600mg of CBD in 56g tube. 46mg/g), applied to affected joints twice a day for 28 days. There is no prescribed amount to be administered each time as the instructions are to roll the salve on in a circular motion in the affected area and then gently rub in. There is no minimum time for the salve to remain on affected joints. Adherence will be assessed via a daily medication log.
Sponsors
OMG Pharma
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: • I1: Adult aged 18 years and over • I2: Able to provide informed consent, comprehend and follow all study procedures. • I:3 Medically diagnosed with Rheumatoid arthritis with at least 4 affected joints. • I:4 Able and willing to have safety blood samples collected at a Laverty pathology collection centre before the baseline and after the endpoint visit. • I5: Agrees to not start using any medical or recreational cannabis during the 4-week study period and 2 week follow up period. • I6: Resides in NSW and can travel to NICM Health Research Institute in Westmead. • I7: Experiences joint pain, discomfort, or fatigue, is dissatisfied with current treatment, and looking for alternative options to manage these symptoms.
Exclusion criteria
Exclusion criteria: • E1: Currently using medicinal or recreational cannabis or have used within the last 3 months. • E2: If female, currently pregnant or planning to become pregnant over the study intervention period. • E3: History of moderate to severe psychological or other mental health conditions. • E4: History of substance use disorder (alcohol, tobacco, cannabis, and other legal, illicit or prescription substances like opioids and benzodiazepines). • E5: Have started using new medication (such as DMARDs, NSAIDs, CS, Opioids, Benzodiazepines, or anti-depressants) within the last 3 months to manage RA. • E6: Participant has any form of surgery booked within 4 weeks of baseline (Day0) and 4 weeks after follow-up (day 42). • E7: Travel outside of NSW during intervention period. • E8: Diagnosis of dementia. • E9: Participants with known allergies to any ingredients in the salve. • E10: Participants with significant dermatological conditions affecting the intended application site/s.
Outcome results
None listed