Evaluation of Cannabidiol (CardiolRx) in the Management of Recurrent Pericarditis: An Open-Label Pilot Study

The primary objective of this study is to evaluate the impact of **CardiolRxTM** on **Recurrent Pericarditis**. Recurrent Pericarditis is a condition characterized by repeated episodes of inflammation of the pericardium, the fibrous sac surrounding the heart. Understanding the effects of CardiolRxTM on this condition is clinically relevant as it may offer insights into potential therapeutic benefits and inform future treatment strategies for patients suffering from this recurrent inflammatory disease.

The clinical trial for **Recurrent Pericarditis** involves a total of 15 participants. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided information regarding the main objective of the trial or the principal inclusion criteria. The selection process and health status of the participants are not explicitly described in the available data.

The clinical trial is designed to evaluate the impact of **CardiolRxTM** on patients with **Recurrent Pericarditis**. This study is structured as an open-label pilot study, which means that both the researchers and participants are aware of the treatment being administered. The trial is categorized under Phase 3, indicating that it is in the later stages of clinical research, focusing on the efficacy and monitoring of adverse reactions in a larger patient group. The estimated recruitment start date is January 1, 2024, with an anticipated end date of December 31, 2024, marking the overall trial duration as approximately one year.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, eligibility criteria will be assessed to ensure that participants meet the necessary conditions for inclusion in the study. Following the initial screening, participants will attend regular follow-up visits, the frequency and specific timing of which will be determined by the study protocol. These visits are crucial for monitoring the participants' health status, assessing the efficacy of the treatment, and recording any adverse events. The study will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement is aligned with the trial's duration, approximately one year, unless specific conditions necessitate early termination. Such conditions may include the occurrence of significant adverse events, withdrawal of consent by the participant, or any other protocol-defined criteria that compromise the safety or integrity of the study. The trial's methodology and design are structured to ensure rigorous data collection and analysis, contributing valuable insights into the treatment of **Recurrent Pericarditis**.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date is January 1, 2024, with an anticipated end date of December 31, 2024. The efficacy assessment will be conducted at predetermined intervals throughout the trial duration. Specific parameters or endpoints for evaluating efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, are not explicitly detailed in the available data. The methods and tools for measuring, collecting, and analyzing these efficacy parameters are also not specified. The trial will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy data collected.