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Active, Not Recruiting

NCT Number: NCT06513507

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammatory Disease Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in inflammatory markers from Baseline to Week 8

    Time frame: 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 outcomes

  1. Change in self-reported symptoms and quality of life from Baseline to Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Raphael Pharma

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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