Conditions: Chronic Venous Insufficiency
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 829
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of the fixed-dose combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic venous insufficiency.

Detailed description:
The drug being tested in this study is the fixed-dose combination of coumarin and troxerutin called Venalot®. Venalot is being tested to treat the symptoms of chronic venous insufficiency. This study will look at symptom relief in people who take Venalot®.

The study will enroll approximately 808 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Combination coumarin + troxerutin extended release tablets
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take two tablets three times a day throughout the study.

This multi-centre trial will be conducted in Brazil. The overall time to participate in this study is up to 18 weeks. Participants will make 6 visits to the clinic.

Arms:
arm 1: Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks. arm 2: Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.

Interventions: intervention 1: Coumarin/troxerutin intervention 2: Placebo
Intervention descriptions: intervention 1: Coumarin + troxerutin fixed-dose combination tablets intervention 2: Coumarin + troxerutin placebo-matching tablets

Protocol document: