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Cannabinoid
CBD Solution for Pericarditis
Phase 2
Waitlist Available
Research Sponsored by Cardiol Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
C-Reactive Protein (CRP) level ≥1.0 mg/dL within prior 7 days OR Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR)
Diagnosis of at least two episodes of recurrent pericarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Study Summary
This trialwill study if a pure CBD solution (CardiolRxTM) is effective and safe for refractory/intolerant pericarditis patients, and if it can reduce or replace corticosteroid therapy.
Who is the study for?
Adults over 18 with recurrent pericarditis, experiencing pain and inflammation shown by CRP levels or cardiac imaging. They must be on stable doses of NSAIDs, colchicine, or corticosteroids. Participants need to use contraception if applicable and cannot have severe kidney/liver issues, current cancer (except non-melanoma skin cancer), or be on certain medications.Check my eligibility
What is being tested?
The trial is testing CardiolRxTM (a pure cannabidiol solution) for its safety and effectiveness in reducing symptoms of recurrent pericarditis. It will also explore whether patients can reduce their current anti-inflammatory medications while taking CardiolRxTM.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects associated with CBD include fatigue, changes in appetite, diarrhea, and potential interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CRP level is high or I have signs of heart inflammation.
Select...
I have had pericarditis at least twice.
Select...
I have experienced severe chest pain due to pericarditis in the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
11-point NRS pain score
CRP change from baseline
Normalized CRP levels
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CardiolRxExperimental Treatment1 Intervention
pharmaceutically produced Cannabidiol
Find a Location
Who is running the clinical trial?
Cardiol Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
190 Total Patients Enrolled
Allen Klein, MDStudy ChairThe Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart takes too long to recharge between beats.My kidney function is severely reduced.I have been diagnosed with cancer, not including non-melanoma skin cancer.You have shown signs of wanting to harm yourself as per a test done during screening.You have experienced a serious type of irregular heartbeat in the past.I am not pregnant or breastfeeding.You have used any cannabis-related products in the last month.My pericarditis is not caused by TB, cancer, infection, radiation, injury, or myocarditis.I am on immunosuppressive medication such as Methotrexate or Cyclosporine.I am taking digoxin or medication for heart rhythm problems.My CRP level is high or I have signs of heart inflammation.Your liver enzymes (ALT or AST) are more than 5 times the normal level, or they are more than 3 times the normal level along with high bilirubin.You have a history of prolonged QT interval.You are currently abusing drugs or alcohol.I am taking stable doses of NSAIDs, colchicine, or corticosteroids for pericarditis.I am a male using reliable birth control or have had a vasectomy.I have had pericarditis at least twice.I am 18 years old or older.I have experienced severe chest pain due to pericarditis in the last week.I am using or willing to use birth control during and for 2 months after the study.I currently have an infection in my blood.You have been diagnosed with pericarditis following specific medical guidelines from 2015.
Research Study Groups:
This trial has the following groups:- Group 1: CardiolRx
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has CardiolRx been verified to satisfy the safety standards of the FDA?
"Our team has assigned CardiolRx a safety rating of 2, considering it is only in Phase 2 and evidence for efficacy is still lacking."
Answered by AI
How many subjects are participating in this experiment?
"Affirmative. According to information on clinicaltrials.gov, this research endeavour is currently recruiting participants; it was initially posted on November 30th 2022 and updated as recently as December 13th 20202. 25 individuals are expected to be enrolled at a single medical site."
Answered by AI
Are researchers currently recruiting participants for this trial?
"That is accurate. According to the information on clinicaltrials.gov, this trial was established and last edited in November/December 2022 respectively, and they are currently seeking 25 participants located at one site."
Answered by AI
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