Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03152578|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : March 15, 2018
This study consists of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating a topical natural health cream containing ß-caryophyllene alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label combination cream to be administered over the subsequent 3 weeks.
Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in individuals who are experiencing pain due to osteoarthritis of the knee.
Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream when used daily over 10 weeks.
Further evaluation will include overall patient satisfaction with the products tested.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: BetaC + Capsaicin Topical Cream Other: BetaC Topical Cream Other: Placebo Topical Cream||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind, Placebo Controlled Crossover Trial With Open Label Extension Of Topical 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin In The Treatment Of Pain Caused By Osteoarthritis Of The Knee|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||May 31, 2019|
Active Comparator: BetaC + Capsacian
1-3 mls BetaC + Capsacian applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.
Other: BetaC + Capsaicin Topical Cream
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
Active Comparator: BetaC Only
1-3 mls BetaC applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.
Other: BetaC Topical Cream
BetaC Topical Cream Cream applied to painful knee area 3 times per day.
Placebo Comparator: Placebo
1-3 mls Placebo applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.
Other: Placebo Topical Cream
Placebo Cream applied to painful knee area 3 times per day.
- Pain Score Diary [ Time Frame: 2 weeks ]Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
- BPI-Short Form [ Time Frame: 12 weeks ]
- Patient's Global Impression of Change [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152578
|Contact: Sara Whynotfirstname.lastname@example.org|
|Canada, Nova Scotia|
|QEII Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Contact: Karim Mukhida, MD 902-473-5030 email@example.com|