Trial reportPloS one2018
LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03653793 (LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study
Who cites it
3 citing papers in PubMed, 7 citations in OpenAlex.
- Xioglican Cream in Italian Patients with Chronic Venous Disease: A Post-Marketing Study Investigating Effects on Clinical and Cutaneous Signs and Symptoms.Advances in therapy · 2023Observational
- Outcome of preventive nursing intervention, prophylactic anticoagulation and the use of the Caprini score on venous thromboembolism after varicose vein surgery.African health sciences · 2023Article
- A nutraceutical formulation combined with sclerofoam-assisted laser treatment ameliorates chronic venous insufficiency.Lasers in medical science · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic Venous Disease is characterized by morphological abnormalities of the venous system. Affected limbs are classified in increasing clinical severity with the Clinical Etiological Anatomical and Pathological system from C0 to C6. Limbs assessed at C3 through C6 meet the criteria of Chronic Venous Insufficiency. Chronic Venous Insufficiency of the Lower Limbs is a very common pathology affecting approximately ~40% of the world's population. This study observes the use of the LivRelief Varicose Vein Cream, a Natural Health Product that is licensed for sale by Health Canada, for use in the treatment of varicose veins.
methodsAn open label, single arm interventional, pilot study was conducted to determine the feasibility of recruitment and data collection in this population. To accomplish this, the cream was provided to all enrolled subjects. Subsequently, objective and subjective measures were performed at baseline and after 6 weeks of at-home use. Recruitment and data collection targets of at least 70% were established and the data collected at both timepoints were compared and analyzed using a paired t-test. Results were also reported as proportions where appropriate.
resultsA total of 32 subjects were enrolled. The pre-defined feasibility objectives for recruitment and data collection were met with the enrolment of 97% of all screened patients and the collection of 94% of all scheduled data. The most significant therapeutic improvement was seen in the results of the Venous Clinical Severity Score where 66% of the treated legs experienced a decrease in severity after 6 weeks of treatment. P values were <0.0001 and 0.0003 for the left and right leg, respectively.
conclusionIt is feasible to recruit and collect data with the chosen outcome assessments within this population. Preliminary results suggest that the product could improve some of the clinical symptoms associated with the presence varicose veins. These results warrant further exploration in a longer, randomized and placebo-controlled study.
trial registrationClinicaltrial.gov: NCT03653793.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.