| CTRI Number |
CTRI/2024/05/067999 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Safety and efficacy study of knee guard in varicose veins with knee pain |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240023-WU, Ver# 2.0, Dated 15 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himesh Chauhan |
| Designation |
Principal Investigator |
| Affiliation |
Ananta Multispeciality Hospital |
| Address |
Department of Surgery, 416, 418, 4th Floor, Centre Point,
New SG Rd, Opp. Vrundavan Heights,
Gota.
Ahmadabad
GUJARAT
382470
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj.
Ahmadabad
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj.
Ahmadabad
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Winnox Cosmeceutics Sdn. Bhd., No. 7, Persiaran Subang Permai, Taman Perindustrian Subang
47610 Subang Jaya Selangor, Malaysia |
|
|
Primary Sponsor
|
| Name |
Winnox Cosmeceutics Sdn. Bhd. |
| Address |
No. 7, Persiaran Subang Permai,
Taman Perindustrian Subang
47610 Subang Jaya Selangor, Malaysia |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himesh Chauhan |
Ananta Multispeciality Hospital |
Department of Surgery, 416, 418, 4th Floor, Centre Point,
New SG Rd, Opp. Vrundavan Heights,
Gota
Ahmadabad
GUJARAT |
9909013286
consultant@novobliss.in |
| Dr Himesh Chauhan |
NovoBliss Research Private Limited |
Department of Clinical Trials, Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Ahmadabad
GUJARAT |
9909013286
consultant@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good general health |
| Patients |
(1) ICD-10 Condition: I83||Varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 should be documented in subject diary.
First time user may feel itching and swelling and stop wearing if condition persist for more than 1 week and should be documented in the subject diary.
Washing Instructions: Gently hand wash in mild detergent. Do not scrub, machine wash or dry wash. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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 Outcome
|
| Outcome |
TimePoints |
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 questionnaire |
All secondary parameters will be assessed on Day 01 before usage, at 1-hour after usage, Day 03, Day 07 and Day 28. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a 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 self-declared knee pain. A maximum of 64 panelists aged 35 to 70 years will be enrolled to get 60 evaluable panelists (30 per group). - 32 panelists with diagnosed varicose veins with self-reported knee pain will be enrolled.
- 32 healthy panelists will be enrolled as a control group.
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.
Visit 01 (Day 01) :Screening, enrolment, evaluations at baseline, test product and diary distribution, followed by evaluations after 1 hour (+10 minutes).
Visit 02 (Day 03 (+1 day) : Evaluations at Day 03 (+1 day).
Visit 03 (Day 07(±2 days)): 1-week evaluations at Day 07 (±2 days).
Visit 04 (Day 28(±2 days)): Subject diary review, followed by end of study evaluations. |