Commercially Available Cannabis Products for Immune Support
1 other identifier
observational
200
1 country
1
Brief Summary
This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 29, 2024
February 1, 2024
1 year
February 20, 2023
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events and Serious Adverse Eventss
Evaluate the safety of commercially available hemp and cannabis products marketed for immune support through assessment of AEs and SAEs. AEs and SAEs will also be collected for the non-user group
To Study Completion, approximately 30 days
Secondary Outcomes (21)
Symptom Improvement
3 days
Symptom Improvement
5 days
Symptom Improvement
10 days
Symptom Improvement
15 days
Symptom Improvement
30 days
- +16 more secondary outcomes
Study Arms (2)
Symptomatic individuals using hemp or cannabis products for immune support
Individuals with symptomatic illness that utilize a proprietary hemp or cannabis product to aid in their recovery
Symptomatic individuals not currently using hemp or cannabis products for immune support
Individuals without symptomatic illness that do not utilize the proprietary hemp or cannabis product to aid in their recovery
Interventions
Cannabinoid and co-active emulsion
Eligibility Criteria
Individuals who are suffering an acute illness
You may qualify if:
- years of age or older
- Able to read and write in English
- Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
- Currently experiencing one or more of the following symptoms due to an acute illness:
- Fever or chills
- Cough
- Fatigue
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Nausea or Vomiting
- Diarrhea
- Agrees to consume their chosen hemp or cannabis product (for the cannabis arm) and to not use a different hemp or cannabis product through the duration of the study
- Agrees to continue to abstain from using hemp or cannabis (for the non-cannabis/hemp using arm)
- +2 more criteria
You may not qualify if:
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Known allergy to any compounds in hemp or cannabis.
- Endorses suicidal intent
- Immunocompromised individuals
- Unwilling or unable to comply with study procedures
- Terminal Illness with life expectancy less than 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Center For Interventional Pain and Spinelead
- Agronomed LLCcollaborator
Study Sites (1)
Center for Interventional Pain and Spine
Bryn Mawr, Pennsylvania, 19010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Kim, MD
Center For Interventional Pain and Spine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
July 13, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
February 29, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share