This multicenter, randomized, double-blind study is a phase III evaluates the safety and effectiveness of CLR prolonged-release tablets in patients with chronic venous insufficiency, has been shown to be effective in reducing the symptoms of itching, edema, spontaneous pain, and night cramps chronic venous disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
Oral heparan sulphate tablets, one tablet administered once daily for one year.
Oral placebo tablets administered once daily for one year.
Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5
Revised Venous Clinical Severity Score (rVCSS) at Visit 5 (V5) compared to Visit 1 (V1) in the two groups. The rVCSS is a clinical scale used to assess the severity of chronic venous disease. The total score ranges from a minimum of 0 (indicating no venous disease) to a maximum of 30 (indicating severe venous disease). Higher scores mean a worse clinical outcome.
Time frame: one year
Participant Self-Assessment of Pain Severity via Visual Analog Scale (VAS) at Visit 2 and Visit 5 Compared to Visit 1
Pain severity assessed by the participant using the Visual Analog Scale (VAS). The unabbreviated scale title is the Visual Analog Scale. The score ranges from a minimum value of 0 (representing "no pain") to a maximum value of 100 (representing "the worst possible pain"). Higher scores mean a worse outcome (greater pain severity). Unit of measure: score
Time frame: one year
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