Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.
The use of the marketed natural product, LivRelief Varicose Veins Cream, was observed in 32 patients with lower limb varicose veins. Participants were recruited from the patient population at The Mayer Institute in Hamilton Ontario, Canada. Patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. The following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification and VCSS (Venous Clinical Severity score). These are assessments performed by the doctor or nurse to determine the severity of their varicose veins and CVI (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (QLES-Q-SF) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. The cream was applied to their varicose veins twice a day for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.
The Mayer Institute
Hamilton, Ontario, Canada
Recruitment feasibility
Recruitment of at least 70% of all eligible participants
Time frame: study duration:~4 weeks
Data Collection
Collection of at least 70% of scheduled data
Time frame: study duration: ~6 to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.