Health Condition 1: null- Leg complaints like ache, heaviness, fullness and tiredness
Conditions
Interventions
Intervention1: Patch-It: Patch is to be applied on the soles of the feet at night before going to sleep for a minimum of 7 hours
Control Intervention1: Placebo: Patch is to be applied on the soles of
Sponsors
Nutriworks Limited
Eligibility
Inclusion criteria
Inclusion criteria: ? Patients capable of giving informed consent to participate in the study of their own free will ? Male and female patients of age between 25 - 60 years. ? Male and female patients with swelling of both the feet and/or ankles ? Optionally, patients could also have leg complaints such as ache, heaviness, tiredness, and fullness. ? The above complaint(s) should be present since at least 3 weeks and should be sufficiently bothersome to seek relief and to interfere with daily activities or restful sleep. ? Baseline average symptoms VAS score of at least 60.
Exclusion criteria
Exclusion criteria: ? Patients with clinical evidence of varicose veins ? Patients with diminished arterial pulsations and/or change in colour or temperature in the legs or ulceration of the skin ? Presence of any complaints of the skin over the sole and foot such as itching, burning, redness or eruptions ? Patients with history of intermittent claudication ? Any cardiac, hepatic, renal, hemopoietic disease, endocrinal or other systemic disease (based on blood chemistry, clinical examination, and history of current medication) ? Patients who give a history that there in no decrease in the swelling of feet after elevation of legs ? Patients with an elevated Jugular Venous Pulse above 4 cm ? Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant ? Known hypersensitivity or allergy to one or more of the ingredients of the IP ? Recent (< 3 months) participation in a clinical trial ? Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study ? Patients with a history or a pre-disposition for deep vein thrombosis (DVT) as evidenced by Wells criteria Subjects with criteria of high probability (>3) will be excluded from the study after taking reasonable care to establish that a given subject is not a high risk case for DVT. ? Patients with clinically significant abnormal laboratory (CBC, ESR, SGPT, Serum Creatinine, Serum proteins, Urine Routine) and / or ECG readings done at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog ScaleTimepoint: Day -3, Day 1, Day 28 & Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Figure of Eight Measurement 2) Global Assessment by the InvestigatorTimepoint: 1) Day 1, Day 28 & Day 56 2) Day 28 & Day 56 | — |
Countries
India
Contacts
Public ContactSeema Damakale
None
Outcome results
None listed