Venous InsufficiencyPhase 2NCT02483962
Venavine Intensive® in the Treatment of Symptoms Associated 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) 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. 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
- Feb 2015to Aug 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;
- 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.
Who cannot join
- 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;
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- 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.
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 in the Treatment of Symptoms Associated With Chronic Venous Insufficiency
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) .
Read the 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.
- 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 no active ingredients.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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, 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.
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.
Measured: 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
The Digimizer programme calculates any changes in the surface area of the skin.
Measured: Every 30 days in a period of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 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
- Primary purpose
- Treatment
- 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
- NCT02483962
- Sponsor's protocol ID
- FayroozKarriem200800851
- Status last verified
- May 2016
- First submitted
- 25 Jun 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 in the Treatment of Symptoms Associated With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02483962
- Acronym / sponsor ID
- FayroozKarriem200800851
- 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
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jun 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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatine capsule | Placebo comparator | Other: Gelatine capsuleGelatine 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. |
| 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, 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 (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
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 no active ingredients. | Other | Gelatine capsule |
| 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. | Other | Venavine Intensive® |
Primary outcome
Severity of chronic venous insufficiency symptoms as measured by the Venous Clinical Severity Score (VCSS)
Time frame: Every 30 days in a period of 90 days
The VCSS is an effective tool in grading the severity of the symptoms of chronic venous insufficiency in response to treatment.
1 secondary outcome
Changes in surface area of the affected skin of the lower limbs as measured by photographs analysed by the Digimizer programme
Time frame: Every 30 days in a period of 90 days
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 4 inclusion and 10 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?
Severity of chronic venous insufficiency symptoms as measured by the Venous Clinical Severity Score (VCSS) (time frame: Every 30 days in a period of 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.