The Mayer Institute
Hamilton, Ontario, L8R 2R3, Canada
NCT Number: NCT03653793
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8R 2R3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.
Other names: Natural Product Number (NPN) 80029349
Time frame: study duration:~4 weeks
Recruitment of at least 70% of all eligible participants
Time frame: study duration: ~6 to 12 weeks
Collection of at least 70% of scheduled data
Delivra, Inc.
Industry
LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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