Clinical study on VRE Lotion in varicose veins
- Conditions
- Health Condition 1: I831- Varicose veins of lower extremities with inflammation
- Registration Number
- CTRI/2023/06/054255
- Lead Sponsor
- Abhinav Health Care Products Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Known cases or Presence of lower limb varicose veins.
2. Subjects willing to provide written informed consent and ready to follow study protocol
1. Subjects who are allergic to any local application of oils, creams or lotion.
2. Intent to undergo surgical treatment for varicose veins within 6 weeks of study participation.
3. Pregnant, breast feeding or planning to become pregnant within the six weeks of study participation.
4. Any dementia or major cognitive dysfunction that would preclude the individual ability to provide informed consent or complete the case record form.
5. Any unstable medical condition including but not limited to cardiovascular, hypertension, moderate to severe kidney disease and moderate to severe liver disease
6. Any medical condition that would preclude the participant or caregiver ability to administer the product daily for the duration of the study
7. An active ulcer at the site of the product application as evaluated during the CEAP assessment at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in chronic venous insufficiency (Varicose veins) of lower limbs by Venous Clinical Severity Score (VCSS) <br/ ><br>from baseline to 8 weeks. (VCSS modified version) <br/ ><br> <br/ ><br>2. Change in clinical symptoms of chronic venous disease (varicose veins) including â?? tingling, aching, burning, pain, muscle cramps, sensation of swelling, throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue. <br/ ><br>Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8
- Secondary Outcome Measures
Name Time Method 1.Change in chronic venous insufficiency (varicose veins) of lower limbs by evaluating CEAP (only clinical C0-C6). <br/ ><br>2. Changes in clinical photographs of the treated leg. <br/ ><br>3. Change in edema by circumferential measurements of the treated limbs from baseline to 8 weeks. <br/ ><br>4. Requirement of compression garment usage & rescue medications. <br/ ><br>5. Safety by evaluating occurrence of AE. <br/ ><br>6. Global assessment of overall safety and Efficacy by physician and subject <br/ ><br>Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8