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

NCT02483962 | Completed Phase 2 DMC

• 1 other identifier: FayroozKarriem200800851
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic

Outcome Measures

Primary Outcomes (1)

• Severity of chronic venous insufficiency symptoms as measured by the Venous Clinical Severity Score (VCSS)

  The VCSS is an effective tool in grading the severity of the symptoms of chronic venous insufficiency in response to treatment.

  Every 30 days in a period of 90 days

Secondary Outcomes (1)

• Changes in surface area of the affected skin of the lower limbs as measured by photographs analysed by the Digimizer programme

  Every 30 days in a period of 90 days

Study Arms (2)

Gelatine capsule

PLACEBO COMPARATOR

Gelatine capsules containing no active ingredients, 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, will be taken once per day, in the morning after breakfast, for 30 days.

Other: Venavine Intensive®

Interventions

Gelatine capsule OTHER

Gelatine capsules containing no active ingredients.

Gelatine capsule

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.

Venavine Intensive®

Eligibility Criteria

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

You may qualify if:

• Females;
• aged 30 to 55 years;
• experiences at least three symptoms from Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) C1-C4 of CVI which include 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 are ameliorated by rest and limb elevation.

You may not qualify if:

• Pregnant or lactating females;
• taking chronic medication for cardiovascular disorder;
• have any chronic diseases that are not sufficiently managed;
• experiencing symptoms from CEAP C5-C6 of CVI, which includes venous ulceration;
• have a previous history of deep vein thrombosis;
• 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
• use 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)