Inflammatory Disease, Rheumatoid Arthritis
Conditions
Keywords
Arthritis Treatment, Cannabinoid Therapy, Anti-CCP
Brief summary
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.
Interventions
DIETARY_SUPPLEMENTCannabigerol (CBG)
The daily dose will consist of 50 mg of CBG. Blood tests will be conducted at Baseline, Week 2, Week 4, Week 6, and Week 8 to monitor inflammatory markers and immune response. Self-reported questionnaires will be completed at Baseline, Week 4, and Week 8 to assess symptoms and quality of life.
Sponsors
Citruslabs
Raphael Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No blinding will be performed in this study. All participants and investigators will know the treatment being administered.
Intervention model description
This is a single-group study with an exploratory longitudinal prospective design aimed at measuring the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, over 25 years of age * Positive anti-CCP blood test * Active RA-related inflammation with at least 2 swollen joints * University graduate * Generally healthy with no uncontrolled chronic disease * Able to read, understand, and sign informed consent * Resides in the USA * Willing to comply with study requirements and avoid other cannabis products during the study period
Exclusion criteria
* Pre-existing chronic conditions preventing adherence * Severe allergic reactions requiring an Epi-pen * Use of opiates in the last 4 weeks or cannabis in the last 8 weeks * Pregnant or breastfeeding women * Recent invasive medical procedure or surgery * Active malignancy or ongoing oncology treatment * Use of cytochrome P450 or 3A4 inhibitors * History of substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory markers from Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6, and Week 8 | Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported symptoms and quality of life from Baseline to Week 8 | Baseline, Week 4, and Week 8 | Evaluation of participant perceptions of the product's effect on symptoms of rheumatoid arthritis and quality of life using a study-specific questionnaire. |
Countries
United States
Outcome results
None listed