Varicose VeinsNCT04933591
Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
A study testing Diosmin / Hesperidin in people with Varicose Veins, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Diosmin / Hesperidin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2020to 28 Sep 2021
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • both female and male
- age from 18 to 50 years old
- Verified diagnosis of chronic venous insufficiency CEAP C2-C4
- signed infromed consent
- Absence of any other treatment 2 weeks before the start of the study and throughout the duration of the study
Who cannot join
- • age less than 18 and more than 50 years
- Previously performed invasive interventions for varicose veins on any of the lower extremities
- No visible varicose veins
- Thrombophlebitis and deep vein thrombosis of the lower extremities in the past
- Taking prohibited pre-trial therapy
- Contraindications to taking Venarus®
- not signed informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pirogov Russian National Research Medical University
Moscow, 117997
About this study
Official title: Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.
Read the detailed description
The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.
Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.
- Conditions
- Varicose Veins
- Being tested
- Diosmin / Hesperidin
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diosmin / HesperidinDrug
Also called Venoactive drug
Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein before and after administration of Venarus® (100 mg hesperidin + 900 mg diosmin) for 2 months Receives: Drug: Diosmin / Hesperidin |
| control group | No intervention | Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr vein. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein at inclusion and 2 months later/ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
Blood samples will be taken from varicose veins and level of cytokine Monocyte Chemoattractant Protein 1 will be measured by immunofluorescence. After 2 months measurement will be repeated and the change will be registered.
Measured: 2 months
Secondary outcomes (1)
Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)
Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Sep 2020
- Primary completion28 Aug 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Zolotukhin, Pirogov Russian National Research Medical University
- Investigators
- Igor Zolotukhin, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933591
- Sponsor's protocol ID
- NIS-ВЕН-19.03
- Status last verified
- Mar 2022
- First submitted
- 7 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
- ClinicalTrials.gov ID
- NCT04933591
- Acronym / sponsor ID
- NIS-ВЕН-19.03
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- 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.
This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.
Detailed description
The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.
Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: Diosmin / HesperidinIndividuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein before and after administration of Venarus® (100 mg hesperidin + 900 mg diosmin) for 2 months |
| control group | No intervention | –Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr vein. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein at inclusion and 2 months later/ |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • both female and male
Key exclusion criteria (7 listed)
- • age less than 18 and more than 50 years
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 |
|---|---|---|
| Diosmin / HesperidinAlso: Venoactive drugVenoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms | Drug | study group |
Primary outcome
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
Time frame: 2 months
Blood samples will be taken from varicose veins and level of cytokine Monocyte Chemoattractant Protein 1 will be measured by immunofluorescence. After 2 months measurement will be repeated and the change will be registered.
1 secondary outcome
Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)
Time frame: 2 months
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 31 Mar 2022.
- 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.
Igor Zolotukhin, PhD principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diosmin / Hesperidin in people with Varicose Veins, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 5 inclusion and 7 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 31 Mar 2022. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein (time frame: 2 months). 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 31 Mar 2022.