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To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with swelling of calf and ankle due to disorder of leg venous reflux.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNS003 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNS003 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global improvement on a five point scale | The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation) | week 12 |
| Number of patients with adverse drug reactions | up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement per symptom on a five point scale | 12 weeks | |
| Change in circumference measurements of calf in centimetres | baseline, 12 weeks | |
| Change in circumference measurements of ankle in centimetres |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| baseline, 12 weeks |
| Subject's impression on improvement on a five point scale | baseline, 12 weeks |
| Number of patients with of adverse events | up to 12 weeks |