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Venavine Intensive® in the Treatment of Symptoms Associated With Chronic Venous Insufficiency

NCT02483962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-19

No results posted yet for this study

Summary

Chronic Venous Insufficiency (CVI) occurs when the veins in the lower limbs can no longer sufficiently pump enough blood back to the heart. Symptoms may include: dull aching, cramping, itching or tingling in the calves, swelling, redness or any colour changes as well as thickening of the skin in the lower limbs. The most common indication of CVI is dilated veins known as varicose veins. CVI is a disorder found more commonly in females. Conventional treatments for CVI include vein ligation or stripping, elastic compression, valve reconstruction and sclerotherapy venous bypass. Amongst other treatment, exercise has also proven to be effective in improving CVI as it increases circulation, by increasing blood returning to the heart. A variety of herbal supplements have been proven to be safe and effective in the treatment of CVI. Red vine leaf extract has also been proven to be useful in the treatment of CVI. Previous studies on the red vine leaf extract have shown that it is an effective and safe treatment of CVI. Studies done on horse chestnut extract have stated that the extract increases venous tone and decreases capillary permeability. Butcher's broom extract has been proven to be effective in the treatment of CVI. There are currently no studies done on the combination of red vine leaf extract, butcher's broom extract, horse chestnut extract and vitamin B6.

The aim of this study is to determine the efficacy of a combination of red vine leaf extract (360mg), horse chestnut extract (60mg), butcher's broom extract (35mg) and pyridoxine (vitamin B6) (3.2mg) in the treatment of symptoms associated with CVI, using a Venous Clinical Severity Score questionnaire (VCSS) .

Conditions

  • Venous Insufficiency

Interventions

OTHER

Gelatine capsule

Gelatine capsules containing no active ingredients.

OTHER

Venavine Intensive®

Gelatine capsules containing 360 mg red vine leaf extract, 60 mg of horse chestnut extract, 35 mg of butchers broom extract and 3,2 mg of vitamin B6.

Sponsors & Collaborators

  • University of Johannesburg

    lead OTHER

Principal Investigators

  • Radmila Razlog, M.TechHom · University of Johannesburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02483962 on ClinicalTrials.gov