Venous InsufficiencyPhase 2NCT02498327
The Efficacy of Venavine Intensive® on the Quality of Life in Females With Chronic Venous Insufficiency
A Phase 2 study testing Gelatine Capsule and Venavine Intensive® in people with Venous Insufficiency, run by University of Johannesburg at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Gelatine Capsule and Venavine Intensive®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Official title: The Efficacy of Red Vine Leaf Extract, Butcher's Broom, Horse Chestnut and Vitamin B6 on the Quality of Life in Females With Chronic Venous Insufficiency
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).
Read the 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.
- Conditions
- Venous Insufficiency
- Being tested
- Gelatine Capsule, Venavine Intensive®
- Keywords
- Chronic
- Medical subject headings
- Venous Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatine CapsuleOther
Gelatine capsules containing only the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Venavine Intensive® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 30 days for 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Radmila Razlog, M.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498327
- Sponsor's protocol ID
- XoliswaRoseMazibuko200729488
- Status last verified
- May 2016
- First submitted
- 13 Jul 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Red Vine Leaf Extract, Butcher's Broom, Horse Chestnut and Vitamin B6 on the Quality of Life in Females With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02498327
- Acronym / sponsor ID
- XoliswaRoseMazibuko200729488
- Conditions
- Venous Insufficiency
- Keywords
- Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatine Capsules | Placebo comparator | Other: Gelatine CapsuleGelatine 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. |
| Venavine Intensive® | Experimental | Other: Venavine Intensive®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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelatine CapsuleGelatine capsules containing only the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine. | Other | Gelatine Capsules |
| Venavine Intensive®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. | Other | Venavine Intensive® |
Primary outcome
The quality of life as measured by the CIVIQ-20
Time frame: Every 30 days for 90 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radmila Razlog, M.TechHom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gelatine Capsule and Venavine Intensive® in people with Venous Insufficiency, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of life as measured by the CIVIQ-20 (time frame: Every 30 days for 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.