Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02483962
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2015-06-25
Brief Title:
Venavine Intensive in the Treatment of Symptoms Associated With Chronic Venous Insufficiency
Sponsor:
University of Johannesburg
Organization:
University of Johannesburg
Study Overview
Official Title:
The Efficacy of Red Vine Leaf Extract Butchers Broom Horse Chestnut and Vitamin B6 in the Treatment of Symptoms Associated With Chronic Venous Insufficiency
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Butchers 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 butchers 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 butchers broom extract 35mg and pyridoxine vitamin B6 32mg in the treatment of symptoms associated with CVI using a Venous Clinical Severity Score questionnaire VCSS
The aim of this study is to determine the efficacy of a combination of red vine leaf extract 360mg horse chestnut extract 60mg butchers broom extract 35mg and pyridoxine vitamin B6 32mg 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 butchers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None