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CompletedNCT03653793Updated Aug 31, 2018

LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

An interventional study of Natural Health Product: LivRelief Varicose Veins Cream in Varicose Veins, sponsored by Delivra, Inc.. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Delivra, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2017, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Varicose Veins

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03

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 32 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Delivra, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    LivRelief Varicose Veins Cream

    Intervention: 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

Interventions

  • OtherNatural Health Product: LivRelief Varicose Veins Cream

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

    Also known as: Natural Product Number (NPN) 80029349

06

What researchers measure

Primary outcomes

  1. Recruitment feasibility

    Recruitment of at least 70% of all eligible participants

    Time frame: study duration:~4 weeks

  2. Data Collection

    Collection of at least 70% of scheduled data

    Time frame: study duration: ~6 to 12 weeks

07

Study locations

1 site
  • The Mayer Institute
    Hamilton, Ontario L8R 2R3, Canada
08

References and documents

Publications

  • Dwyer HC, Baranowski DC, Mayer PV, Gabriele S. LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study. PLoS One. 2018 Dec 31;13(12):e0208954. doi: 10.1371/journal.pone.0208954. eCollection 2018. PubMed 30596677 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03653793
Lead sponsor
Delivra, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2018
Start date
May 23, 2017
Primary completion
Aug 28, 2017
Completion
Aug 28, 2017
Last update
Aug 31, 2018

Study contacts

Perry V Mayer, MD
principal investigator · The Mayer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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