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OpenTrials
Completed

NCT Number: NCT03653793

LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

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.

Completed

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 19 years of age.
  • Presence of lower limb varicose veins.

Exclusion criteria

  • Allergy to witch-hazel or any allergies in the cream.
  • Intent to undergo surgical treatment varicose veins within the next six weeks.
  • Pregnant or breastfeeding or planning to be pregnant.
  • Any Dementia or Major Cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the Case Report Form.
  • Any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease)
  • Any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study.
  • An active ulcer at the site of product application (as evaluated during CEAP screening).

Treatment and study plan

Natural Health Product: LivRelief Varicose Veins Cream

Other

This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.

Other names: Natural Product Number (NPN) 80029349

Primary outcomes

  1. Recruitment feasibility

    Time frame: study duration:~4 weeks

    Recruitment of at least 70% of all eligible participants

  2. Data Collection

    Time frame: study duration: ~6 to 12 weeks

    Collection of at least 70% of scheduled data

Sponsors and collaborators

Lead sponsor

Delivra, Inc.

Industry

Registry information

Official study title

LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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