Varicose Veins with Self-declared Knee PainNCT06440889
A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists with Varicose Vein and Knee Pain.
A study testing Bio-Ray Knee Guard in people with Varicose Veins with Self-declared Knee Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins with Self-declared Knee Pain
- What is being tested?
- Bio-Ray Knee Guard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndia
- Study dates
- 31 May 2024to 4 Oct 2024
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
- Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
- Panelist of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, vasectomy or abstinence).
- 32 panelists with clinical diagnosis of varicose veins in any of the leg with C2 class as per CEAP classification (Appendix II), with self-declared knee pain.
- 32 healthy panelists will be enrolled.
- Documented written informed consent from the panelists.
- Panelists having willingness and ability to adhere to study directions, and agreeing not to use any other or wear any other similar product at the same designated site for this study and returning for all specified visits for follow-up.
- Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment.
Who cannot join
- Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the panelists unfit to take part in the study.
- Any recent surgery which may hinder in the study specific assessments and overall outcome.
- Panelists with class C3 to C6 of CEAP classification.
- Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
- Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
- Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
- Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
- Panelists who are not willing to adhere to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with Varicose Vein and Self-Declared Knee Pain.
Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain.
Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled.
Read the detailed description
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.
Panelists shall be instructed to visit the facility for the following scheduled visits:
Visit 01 (Day 01): Screening, enrolment, evaluations at baseline, test product and *subject diary distribution, followed by evaluations after 1 hour (+10 minutes).
Visit 02 (Day 03 +1 day): Evaluations at Day 03 (+1 day).
Visit 03 (07 ±2 days): 1-week evaluations at Day 07 (±2 days).
Visit 04 (28±2 days): Subject diary review, followed by end of study evaluations.
- Being tested
- Bio-Ray Knee Guard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Ray Knee GuardDevice
Wear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours)
| Study group | Role | What they receive |
|---|---|---|
| Varicose Vein Group | Experimental | Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. Receives: Device: Bio-Ray Knee Guard |
| Healthy Group | Other | Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. Receives: Device: Bio-Ray Knee Guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Parameters (D-dimer)
To assess the effectiveness of the test product in terms of determining the biomarker D-dimer.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (C-reactive protein)
To assess the effectiveness of the test product in terms of determining the biomarker C-reactive protein.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (Rheumatoid factor)
To assess the effectiveness of the test product in terms of determining the biomarker rheumatoid factor.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (anti-CCP antibodies)
To assess the effectiveness of the test product in terms of determining the biomarker anti-CCP antibodies.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (MCP-1)
To assess the effectiveness of the test product in terms of determining the biomarker MCP-1.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (IL-6)
To assess the effectiveness of the test product in terms of determining the biomarker IL-6.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Parameters (TNF-α)
To assess the effectiveness of the test product in terms of determining the biomarker TNF-α.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (SFJ)
To assess the effectiveness of the test product in terms of change in blood circulation of saphenofemoral junction by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (GSV)
To assess the effectiveness of the test product in terms of change in blood circulation of great saphenous vein by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in Blood Circulation (SSV)
To assess the effectiveness of the test product in terms of change in blood circulation of small saphenous veins by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (SFJ)
To assess the effectiveness of the test product in terms of change in blood valve function of saphenofemoral junction by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (GSV)
To assess the effectiveness of the test product in terms of change in blood valve function of great saphenous vein by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in blood valve function (SSV)
To assess the effectiveness of the test product in terms of change in blood valve function of small saphenous vein by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (SFJ)
To assess the effectiveness of the test product in terms of change in vessel anatomy of saphenofemoral junction by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (GSV)
To assess the effectiveness of the test product in terms of change in vessel anatomy of great saphenous vein by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in vessel anatomy (SSV)
To assess the effectiveness of the test product in terms of change in vessel anatomy of small saphenous vein by duplex ultrasound.
Measured: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
Change in overall health of knee joint.
To assess the effectiveness of the test product in terms of change in overall health of knee joint based on questionnaire.
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
Change in VAS pain score (only for vericose vain panelist)
To assess the effectiveness of the test product in terms of change in VAS pain score of Knee. Where 0= No pain 10 = worst pain
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology)
To assess effectiveness of the test product in terms of change in CEAP classification of the severity of varicose vein. C0 = No visible or palpable signs of venous disease, C1= Telangiectasias or reticular veins C2 = Varicose vein and
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
Secondary outcomes (5)
Change in blood pressure
To assess the effectiveness of the test product in terms of change in blood pressure of upper leg (standing or sitting).
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in blood pressure
To assess the effectiveness of the test product in terms of change in blood pressure of lower leg (standing or sitting).
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in ankle-brachial index
To assess the effectiveness of the test product in terms of change in ankle-brachial index.
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in body leg temperature
To assess the effectiveness of the test product in terms of change in body leg temperature by Infrared camera (thermal image).
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Overall improvement in symptoms and satisfaction with the use of test product
To assess the effectiveness of the test product in terms of overall improvement in symptoms and satisfaction with the use of test product using subjective perception questionnaire.
Measured: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start31 May 2024
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins with Self-declared Knee PainStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Winnox Cosmeceutics Sdn. Bhd
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr. Nayan K Patel K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440889
- Sponsor's protocol ID
- NB240023-WU
- Status last verified
- Feb 2025
- First submitted
- 27 May 2024
- Last updated
- 3 Mar 2025
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with Varicose Vein and Self-Declared Knee Pain.
- ClinicalTrials.gov ID
- NCT06440889
- Acronym / sponsor ID
- NB240023-WU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Winnox Cosmeceutics Sdn. Bhd
- Study start
- 31 May 2024 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 4 Jun 2024 (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.
Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain.
Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled.
Detailed description
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.
Panelists shall be instructed to visit the facility for the following scheduled visits:
Visit 01 (Day 01): Screening, enrolment, evaluations at baseline, test product and *subject diary distribution, followed by evaluations after 1 hour (+10 minutes).
Visit 02 (Day 03 +1 day): Evaluations at Day 03 (+1 day).
Visit 03 (07 ±2 days): 1-week evaluations at Day 07 (±2 days).
Visit 04 (28±2 days): Subject diary review, followed by end of study evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| Varicose Vein Group | Experimental | Device: Bio-Ray Knee GuardEbene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. |
| Healthy Group | Other | Device: Bio-Ray Knee GuardEbene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
- Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
- Panelist of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, vasectomy or abstinence).
- 32 panelists with clinical diagnosis of varicose veins in any of the leg with C2 class as per CEAP classification (Appendix II), with self-declared knee pain.
- 32 healthy panelists will be enrolled.
Key exclusion criteria (8 listed)
- Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the panelists unfit to take part in the study.
- Any recent surgery which may hinder in the study specific assessments and overall outcome.
- Panelists with class C3 to C6 of CEAP classification.
- Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
- Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
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 |
|---|---|---|
| Bio-Ray Knee GuardWear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours) | Device | Healthy Group, Varicose Vein Group |
Primary outcome
Change in Blood Parameters (D-dimer)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker D-dimer.
Change in Blood Parameters (C-reactive protein)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker C-reactive protein.
Change in Blood Parameters (Rheumatoid factor)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker rheumatoid factor.
Change in Blood Parameters (anti-CCP antibodies)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker anti-CCP antibodies.
Change in Blood Parameters (MCP-1)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker MCP-1.
Change in Blood Parameters (IL-6)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker IL-6.
Change in Blood Parameters (TNF-α)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of determining the biomarker TNF-α.
Change in Blood Circulation (SFJ)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of saphenofemoral junction by duplex ultrasound.
Change in Blood Circulation (GSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of great saphenous vein by duplex ultrasound.
Change in Blood Circulation (SSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood circulation of small saphenous veins by duplex ultrasound.
Change in blood valve function (SFJ)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of saphenofemoral junction by duplex ultrasound.
Change in blood valve function (GSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of great saphenous vein by duplex ultrasound.
Change in blood valve function (SSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in blood valve function of small saphenous vein by duplex ultrasound.
Change in vessel anatomy (SFJ)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of saphenofemoral junction by duplex ultrasound.
Change in vessel anatomy (GSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of great saphenous vein by duplex ultrasound.
Change in vessel anatomy (SSV)
Time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
To assess the effectiveness of the test product in terms of change in vessel anatomy of small saphenous vein by duplex ultrasound.
Change in overall health of knee joint.
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess the effectiveness of the test product in terms of change in overall health of knee joint based on questionnaire.
Change in VAS pain score (only for vericose vain panelist)
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess the effectiveness of the test product in terms of change in VAS pain score of Knee. Where 0= No pain 10 = worst pain
Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology)
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
To assess effectiveness of the test product in terms of change in CEAP classification of the severity of varicose vein. C0 = No visible or palpable signs of venous disease, C1= Telangiectasias or reticular veins C2 = Varicose vein and
5 secondary outcomes
Change in blood pressure
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in blood pressure
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in ankle-brachial index
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Change in body leg temperature
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group.
Overall improvement in symptoms and satisfaction with the use of test product
Time frame: On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage.
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 3 Mar 2025.
- Individual participant dataSharing planned: No
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.
Dr. Nayan K Patel K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-Ray Knee Guard in people with Varicose Veins with Self-declared Knee Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.
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 8 inclusion and 8 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 3 Mar 2025. 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 India. 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 in Blood Parameters (D-dimer) (time frame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.). The study lists 19 primary outcomes in all. 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 3 Mar 2025.