Clinical trial NCT06440889: A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists with Varicose Vein and Knee Pain.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins with Self-declared Knee Pain
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Winnox Cosmeceutics Sdn. Bhd
First posted: 2024-06-04
Enrollment: 63
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
2. Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
3. 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).
4. 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.
5. 32 healthy panelists will be enrolled.
6. Documented written informed consent from the panelists.
7. 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.
8. Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment.

Exclusion Criteria:

1. 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.
2. Any recent surgery which may hinder in the study specific assessments and overall outcome.
3. Panelists with class C3 to C6 of CEAP classification.
4. Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
5. Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
6. Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
7. Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
8. Panelists who are not willing to adhere to the study protocol.

Primary outcomes:
measure: Change in Blood Parameters (D-dimer)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (C-reactive protein)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (Rheumatoid factor)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (anti-CCP antibodies)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (MCP-1)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (IL-6)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Parameters (TNF-α)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Circulation (SFJ)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Circulation (GSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in Blood Circulation (SSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in blood valve function (SFJ)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in blood valve function (GSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in blood valve function (SSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in vessel anatomy (SFJ)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in vessel anatomy (GSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in vessel anatomy (SSV)
timeFrame: On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group.
measure: Change in overall health of knee joint.
timeFrame: 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.
measure: Change in VAS pain score (only for vericose vain panelist)
timeFrame: 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.
measure: Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology)
timeFrame: 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:
measure: Change in blood pressure
timeFrame: 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.
measure: Change in blood pressure
timeFrame: 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.
measure: Change in ankle-brachial index
timeFrame: 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.
measure: Change in body leg temperature
timeFrame: 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.
measure: Overall improvement in symptoms and satisfaction with the use of test product
timeFrame: 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.
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: NovoBliss Research Pvt.Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel K Patel
role: PRINCIPAL_INVESTIGATOR
References: