A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.

N/AActive Not RecruitingNCT06513507

Raphael Pharma12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Inflammatory Disease

Interventions

Cannabigerol (CBG)DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

Change in inflammatory markers from Baseline to 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.

Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8

Secondary Outcomes

Change in self-reported symptoms and quality of life from Baseline to 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.

Time frame: Baseline, Week 4, and Week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.