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NCT05743985 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults
A NA study of Inflammatory Response and Health, Subjective, sponsored by Formula30A.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
- 6
- Study locations
NCT05743985: Completed NA study of Inflammatory Response and Health, Subjective, sponsored by Formula30A.
NCT05743985 is a NA study of Inflammatory Response and Health, Subjective that has completed, run by Formula30A. The registered enrollment target is 69 participants, below the 174-participant average among 16 other Inflammatory Response trials with a reported enrollment target (60% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05743985, a NA study of Inflammatory Response and Health, Subjective, has completed, sponsored by Formula30A.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
- 6
- Study locations
Study Summary
The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over. The main questions it aims to answer are: * What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores? * Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers? * Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG? * What adverse effects, if any, are associated with CBG use? Over the course of the 12-week study, participants will: * Take baseline MSQ and SF-36 surveys, as well as a clinical visit with blood draws for HSCRP, ESR, and PSA testing * Consume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout period * Complete biweekly SF-36 surveys as well as MSQ surveys every 4 weeks * Attend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)
Primary Outcome
Change from baseline scores as measured by the Medical Symptom Questionnaire after 8 weeks. A total score of 20 or less is not clinically significant, 20 to 49 indicates mild toxicity, 50 to 99 indicates moderate toxicity, and 100 and above indicates severe toxicity.
Conditions Studied
Interventions
- OTHER Cannabigerol
Study Locations (6)
Texas
- Institute for Hormonal Balance - Arlington
- NP Care Clinic - Denton
- Infectious Disease Specialists - Edinburg
- Modern Medicine - Forney
- Melville Medicine - Southlake
Puerto Rico
- Java Med - Ceiba
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-04-30 |
| Phase | NA |
What the finished NCT05743985 record still lists
NCT05743985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 174-participant average among 16 other Inflammatory Response trials with a reported enrollment target (60% lower).
The record links to 4 conditions, with Inflammatory Response appearing as the primary indexed condition, and to 1 intervention - of which Cannabigerol is the first listed.
NCT05743985 lists 6 locations in 2 states (Texas, Puerto Rico).
Frequently Asked Questions
What is clinical trial NCT05743985 about?
NCT05743985 is a clinical study titled "Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults". The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over. The main questions it aims to answer are: * What effect, if any, does daily oral consumption of 50...
What is the current status of trial NCT05743985?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2022-08-01. Estimated completion is 2024-04-30.
What conditions does trial NCT05743985 study?
This clinical trial studies the following conditions: Inflammatory Response, Health, Subjective, Side Effect, Adverse Effect.
What interventions are being tested in trial NCT05743985?
The interventions under investigation include: Cannabigerol (OTHER).
Who is sponsoring clinical trial NCT05743985?
This trial is sponsored by Formula30A, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05743985 being conducted?
This trial has 6 study locations across Texas, Puerto Rico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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69 7th of 16 higher than 10 of 16 other Inflammatory Response trials
participants (enrollment target), bucketed by value
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