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

NCT02498327 | Completed Phase 2 DMC

• 1 other identifier: XoliswaRoseMazibuko200729488
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic

Outcome Measures

Primary Outcomes (1)

• The quality of life as measured by the CIVIQ-20

  The CIVIQ-20 is made up of 20 multiple choice questions subdivided into four categories: psychology, pain, physical repercussion and social repercussions. The questions are equally weighted and the value indicates the degree of deterioration of quality of life; 0 being the highest quality of life and 100 being the lowest. It has been tested to be a reliable measurement tool in evaluating the quality of life in those with CVI.

  Every 30 days for 90 days

Study Arms (2)

Gelatine Capsules

PLACEBO COMPARATOR

Gelatine capsules containing only inactive ingredients (starch amyral white, di-calcium phosphate DC and magnesium stearate fine), will be taken once per day, in the morning after breakfast, for 30 days. These capsules will be of identical appearance to the experimental comparator.

Other: Gelatine Capsule

Venavine Intensive®

EXPERIMENTAL

Gelatine capsules containing the active ingredients of: 360 mg Red Vine Leaf extract, 60 mg of Horse Chestnut extract, 35 mg of Butcher's 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, will be taken once per day, in the morning after breakfast, for 30 days.

Other: Venavine Intensive®

Interventions

Gelatine Capsule OTHER

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

Gelatine Capsules

Venavine Intensive® OTHER

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.

Venavine Intensive®

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Venous Insufficiency; Bronchiolitis Obliterans Syndrome

Interventions

Gelatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Radmila Razlog, M.TechHom

  University of Johannesburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)