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Active, not recruitingNCT06513507Updated Nov 21, 2024

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

An interventional study of Cannabigerol (CBG) in Rheumatoid Arthritis and Inflammatory Disease, sponsored by Raphael Pharma. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Raphael Pharma · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
25 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Inflammatory Disease

Keywords

  • Arthritis Treatment
  • Cannabinoid Therapy
  • Anti-CCP
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 12 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with Raphael Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    CBG Treatment

    Participants will receive 0.5 milliliters of purified cannabigerol (CBG) in sesame oil once daily in the evening for a duration of eight weeks.

    Dietary Supplement: Cannabigerol (CBG)

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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Citruslabs
    Santa Monica, California 90404, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06513507
Lead sponsor
Raphael Pharma
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Jul 22, 2024
Start date
Jun 3, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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