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

NCT ID: NCT06513507

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-12-31

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.

Conditions

Rheumatoid Arthritis; Inflammatory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cannabigerol (CBG)

Intervention Type: 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.

Interventions

Cannabigerol (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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Raphael Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20441

Identifier Type: -

Identifier Source: org_study_id