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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
Apothyx, Co.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 2, 2022
    Last Updated
    June 6, 2022
    Sponsor
    Apothyx, Co.
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    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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