Topical CBD for Musculoskeletal Pain
Primary Purpose
Pain
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GoodFOR Pain
Icy Hot
Tiger Balm
Bengay
CBD Clinic Muscle and Joint Pain Relief Ointment
CBD FX CBD Muscle and Joint Cream: Cooling Formula
Essential Wholesale Muscle Gel
Extract Labs Muscle Cream
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- has Pain
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Pain Before/After Application
McGill Pain Questionnaire
Secondary Outcome Measures
Efficiency
Time and Duration of Pain Relief
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05411913
Brief Title
Topical CBD for Musculoskeletal Pain
Official Title
Immediate Effect of Topical CBD for Musculoskeletal Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Apothyx, Co.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Various OTC and CBD containing topicals are evaluated in a double blind survey. Each sample has a QR code that is to be scanned before applying. The QR code links to a survey form with application instructions and collects participant information and feedback.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Individuals are provided with a sample of topical substance to apply to a localized region of pain.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Everything is masked by QR code - participant and intervention
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GoodFOR Pain
Intervention Description
GoodFOR Pain is a FDA registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
Icy Hot
Intervention Description
a FDA OTC registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
Tiger Balm
Intervention Description
a FDA OTC registered topical analgesic
Intervention Type
Drug
Intervention Name(s)
Bengay
Intervention Description
a FDA OTC registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
CBD Clinic Muscle and Joint Pain Relief Ointment
Intervention Description
a non FDA registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
CBD FX CBD Muscle and Joint Cream: Cooling Formula
Intervention Description
a non FDA registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
Essential Wholesale Muscle Gel
Intervention Description
a non FDA registered topical analgesic.
Intervention Type
Drug
Intervention Name(s)
Extract Labs Muscle Cream
Intervention Description
a non FDA registered topical analgesic.
Primary Outcome Measure Information:
Title
Pain Before/After Application
Description
McGill Pain Questionnaire
Time Frame
5 min post intervention
Secondary Outcome Measure Information:
Title
Efficiency
Description
Time and Duration of Pain Relief
Time Frame
5 min post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
has Pain
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical CBD for Musculoskeletal Pain
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