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The Efficacy of Venavine Intensive® on the Quality of Life in Females With Chronic Venous Insufficiency

NCT02498327 · 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) is impaired venous return which results in lower limbs symptoms that include pain, swelling and dermatologic changes. CVI is a condition that affects both males and females, but is more prevalent in females due to the effect of progesterone on vascular tissue resulting in the dilation of veins. The predisposing factors for CVI include: female gender, long periods of standing, decreased physical activity, obesity, poor nutrition, metabolic syndrome, tight and restrictive clothing as well as advanced age, constipation, pregnancy and ascites. Conventional treatment may involve surgery, compression stockings, laser therapy, sclerotherapy and venoactive drugs, which are aimed at improving the appearance of varicose veins and decreasing pain and swelling.

The combination of Red Vine, Butcher's Broom, Horse Chestnut and Vitamin B6 is an over-the counter herbal preparation, which is used to treat the symptoms associated with CVI. Studies done on each of the preparation's individual constituents demonstrate their efficacy in improving blood circulation, thereby alleviating symptoms associated with venous stasis. The individual extracts improve venous tone and blood circulation, however there are no studies on the combined effect of these individual ingredients and their efficacy on the quality of life of females affected by CVI.

The aim of this study is to determine the efficacy of a combination of Red Vine Leaf extract, Butcher's Broom, Horse Chestnut and Vitamin B6 on the quality of life in female participants with CVI, using the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20).

Conditions

  • Venous Insufficiency

Interventions

OTHER

Gelatine Capsule

Gelatine capsules containing only the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.

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 as well as the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.

Sponsors & Collaborators

  • University of Johannesburg

    lead OTHER

Principal Investigators

  • Radmila Razlog, M.TechHom · University of Johannesburg

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT02498327 on ClinicalTrials.gov