Clinical study on VRE Lotion in varicose veins

VRE-Lotion in the treatment of chronic venous insufficiency (varicose veins) of lower limbs: A 8-week single arm clinical study. - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054255

Enrollment

Registered

2023-06-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I831- Varicose veins of lower extremities with inflammation

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Known cases or Presence of lower limb varicose veins. 2. Subjects willing to provide written informed consent and ready to follow study protocol

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1.Change in chronic venous insufficiency (Varicose veins) of lower limbs by Venous Clinical Severity Score (VCSS) from baseline to 8 weeks. (VCSS modified version) 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. Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8	—

Measure

Time frame

1.Change in chronic venous insufficiency (Varicose veins) of lower limbs by Venous Clinical Severity Score (VCSS) from baseline to 8 weeks. (VCSS modified version) 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. Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8

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Secondary

Measure	Time frame
1.Change in chronic venous insufficiency (varicose veins) of lower limbs by evaluating CEAP (only clinical C0-C6). 2. Changes in clinical photographs of the treated leg. 3. Change in edema by circumferential measurements of the treated limbs from baseline to 8 weeks. 4. Requirement of compression garment usage & rescue medications. 5. Safety by evaluating occurrence of AE. 6. Global assessment of overall safety and Efficacy by physician and subject Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8	—

Measure

Time frame

1.Change in chronic venous insufficiency (varicose veins) of lower limbs by evaluating CEAP (only clinical C0-C6). 2. Changes in clinical photographs of the treated leg. 3. Change in edema by circumferential measurements of the treated limbs from baseline to 8 weeks. 4. Requirement of compression garment usage & rescue medications. 5. Safety by evaluating occurrence of AE. 6. Global assessment of overall safety and Efficacy by physician and subject Timepoint: Screening visit, Baseline visit, Week 2, Week 4 & Week 8

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results