The Efficacy of Venavine Intensive® on the Quality of Life in Females With Chronic Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      The study is a double-blind, placebo-controlled study of forty female participants, aged
      thirty to fifty-five years, conducted over a period of ninety days.The research sample will
      be shared by another Homoeopathy Master's student Fayrooz Karriem who is researching "The
      efficacy of the combination of Red Vine extract, Butcher's Broom, Horse Chestnut and Vitamin
      B6 in the treatment of chronic venous insufficiency associated symptoms. Participants will be
      recruited by means of advertisements at the University of Johannesburg (UJ) Health Clinics.

      The research sample will be randomly divided into two groups (X and Y), in matched pairs
      according to age and severity of symptoms. Participants will select a remedy from one of the
      boxes, marked with X or Y, thereby allocating themselves to either the experimental group or
      the control group.

      At the first consultation, respondents will undergo a screening test for eligibility to
      participate in the study. This will be done by means of the inclusion and exclusion criteria.
      Participants that are eligible to take part in the study will be given an information and
      consent form to read and sign. If any questions arise, they will be answered by the
      researcher. A physical examination will be conducted using a modified University of
      Johannesburg Homoeopathy case taking form. The physical examination will include vital signs
      and examination procedure for CVI. Participants will be asked to fill in the CIVIQ-20
      questionnaire with the assistance of the researcher.

      At the end of the first consultation participants will be given either the combination of Red
      Vine, Butcher's Broom, Horse Chestnut and Vitamin B6 capsules or placebo capsules and will be
      advised to start taking the capsules the next morning. Participants will be given enough
      capsules to last them until the next consultation (30 capsules); participants will also be
      advised not to change their normal routine during the course of the study. If it happens that
      the participants take aspirin during the course of the study, they will be required to report
      it to the researcher. Aspirin has anti-coagulant effects which may have an effect on CVI.

      On day thirty of the study, participants will have the first follow up consultation. A
      physical examination will be conducted and participants will fill out the CIVIQ-20
      questionnaire based on their experience over the past thirty days. At the end of the first
      follow up, participants will be given thirty capsules of the herbal combination or placebo
      (as selected by the participant after the first consultation) to be taken as previously
      instructed.

      On day sixty a second follow up consultation will be conducted and the procedure followed on
      day thirty will be repeated on day sixty.

      The final follow up consultation will be on day ninety, where a physical examination will be
      conducted and the CIVIQ-20 questionnaire will be completed. On the last day no capsules will
      be given.

      All data collected by the questionnaire, will be statistically analysed with the assistance
      of a statistician at Statkon, UJ. The between groups comparison will be analysed using the
      Mann-Whitney U-test. The comparison within the groups will be conducted using the Friedman
      test and differences over time will be analysed using the Wilcoxon post hoc test.
    

Intervention name(s): Gelatine Capsule; Venavine Intensive®
Intervention type(s): Other; Other
Intervention description(s): Gelatine capsules containing only the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Chronic