Venavine Intensive® in the Treatment of Symptoms Associated With Chronic Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 2

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) .
    

Detailed description: 
      This study is a 90 day, match paired, double-blinded, placebo-controlled study involving
      forty females participants between the ages of 30 and 55. Participants will be recruited via
      advertisements placed at the University of Johannesburg (UJ) Health Centre and on the campus.
      This sample group will be shared with another Homoeopathy Masters student, Xoliswa Mazibuko,
      who will be evaluating the changes in the quality of life using combination of red vine leaf
      extract, butcher's broom, horse chestnut extract and vitamin B6.

      All consultations will take place at the UJ Health Centre, Doornfontein campus. The initial
      consultation will consist of signing of the Participant Information and Consent form as well
      as a Photograph Consent Form, followed by a screening test to confirm if participants qualify
      to participate in the study. All symptoms will be evaluated according to the Venous Clinical
      Severity Score (VCSS) questionnaire. Photographs of physical symptoms will also be taken,
      with the consent of the participant, in the initial consultation. Participants will be
      matched according to their age and severity of their symptoms. The bottles containing the
      placebo capsules will be placed in one box and the bottles containing the experimental
      capsules will be placed in another box. The boxes will be labelled X and Y. Each bottle will
      contain either 30 placebo capsules or 30 experimental capsules, as per their box group. The
      participants will then select a bottle from one of the boxes , thereby allocating themselves
      to either the experimental group or the control group. The participants will be requested to
      ingest one capsule from their selected bottle, every morning after breakfast for 30
      consecutive days.

      Follow up consultations will take place on days thirty, sixty and ninety. At each follow up
      consultation, the participants will be asked to complete the VCSS questionnaire, with the
      help of the researcher, and photographs of the same anatomical landmarks as taken in the
      initial consultation, will be taken. All photographs will be analysed by the Digimizer
      programme, which will calculate any changes in surface area from week one to week twelve.
      Photographs will be taken in such a way that the dignity and privacy of the participant is
      maintained.

      Participants will be given medication for the next thirty days at each follow-up consultation
      excluding the final consultation (day 90).

      If any other treatment or intervention is used during the duration of the study, they will be
      requested to notify the researcher.

      Data will be collected from the questionnaire and analysed statistically with the assistance
      of a statistician at Statkon. Differences between the Inter-group will be analysed using the
      Friedman test with Wilcoxon post hoc test. To compare the different sets of data between the
      Intra-group, the Mann-Whitney test will be used. All photographs will be analysed by
      Digimizer programme.
    

Intervention name(s): Gelatine capsule; Venavine Intensive®
Intervention type(s): Other; Other
Intervention description(s): Gelatine capsules containing no active ingredients.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic