Health Condition 1: I83- Varicose veins of lower extremities
Conditions
Interventions
Intervention1: Bio-Ray Knee Guard: For first time user, wear the test product in daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours and same sho
Sponsors
Winnox Cosmeceutics Sdn. Bhd.
Eligibility
Inclusion 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 (by surgeon) (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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in blood parameters to identify potent biomarker for the development of varicose veins. 2 Change in blood circulation, blood valve function, vessel anatomy in saphenofemoral junction (SFJ), great saphenous vein (GSV) and small saphenous vein (SSV) using duplex ultrasound of the affected leg. 3 Change in overall health of knee joints based on questionnaire. 4 Change in VAS pain score. 5 Change in CEAP classification of the severity of varicose veins.Timepoint: Blood parameters and Duplex Ultrasound will be assessed at Day 01 before usage and at Day 28 of test product usage. All other parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in blood pressure of upper and lower leg (standing or sitting) 2 Change in ankle-brachial index 3 Change in body leg temperature by Infrared camera thermal image 4 Overall improvement in symptoms and satisfaction with the use of test product using subjective perception questionnaireTimepoint: All secondary parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed