LivRelief Varicose Veins Cream in the Treatment of Varicose Veins
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03653793|
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins||Other: Natural Health Product: LivRelief Varicose Veins Cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This was a single arm pilot study to determine the feasibility of conducting an appropriately sized RCT within the same population using the same clinical outcome measures.
Eligible adult patients of the clinic with varicose veins were asked to use the cream as directed on the packaging for 6-weeks and the post-treatment measures were compared to baseline data. This study also provided SDs of the sample for comparison to the study population.
|Masking:||None (Open Label)|
|Official Title:||LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study|
|Actual Study Start Date :||May 23, 2017|
|Actual Primary Completion Date :||August 28, 2017|
|Actual Study Completion Date :||August 28, 2017|
Experimental: LivRelief Varicose Veins Cream
All subjects were provided with an adequate supply of the Natural Health Product LivRelief Varicose Veins cream for 6 weeks of at home use.
Other: Natural Health Product: LivRelief Varicose Veins Cream
This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.
Other Name: Natural Product Number (NPN) 80029349
- Recruitment feasibility [ Time Frame: study duration:~4 weeks ]Recruitment of at least 70% of all eligible participants
- Data Collection [ Time Frame: study duration: ~6 to 12 weeks ]Collection of at least 70% of scheduled data
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): NCT03653793
|The Mayer Institute|
|Hamilton, Ontario, Canada, L8R 2R3|
|Principal Investigator:||Perry V Mayer, MD||The Mayer Institute|