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

Sponsored by University of Johannesburg

About this trial

Last updated 9 years ago

Study ID

XoliswaRoseMazibuko200729488

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
30 to 55 Years
Female
Female

Trial Timing

Ended 10 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

- Females between the ages thirty to fifty five years;

- experiencing at least three symptoms from Clinical, Etiology, Anatomy and Pathophysiology (CEAP) Classification C1-C4 of CVI, which includes varicose veins, tired or heavy legs, pain in the legs, tingling calves, venous oedema, induration of the legs, brown discolouration in the legs, skin changes such as erythema in the legs; and

- symptoms must be aggravated by walking/standing and symptoms ameliorated by rest and limb elevation.

No

Exclusion Criteria

- Are pregnant or lactating;

- are on chronic medication for cardiovascular disorder;

- have any chronic diseases that are not sufficiently managed;

- are experiencing CEAP C5-C6 of CVI, including venous ulceration;

- are on Warfarin or blood thinning medication;

- have any liver or kidney pathologies;

- are hypersensitive to any/all herbal extracts;

- are on any treatment (herbal or conventional) for CVI; and/or

- are using compression stockings or Kinesio Taping therapy.