Clinical Study of Non-inferiority Between Aesculus Hippocastanum 50mg, Polygonum Acre 10mg, Smilax Pepyracea 40mg, Rutin 20mg Versus Diosmin 450mg and Hesperidin 50mg Tablets in Chronic Venous Insufficiency After 3 Months of Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs

• Clinical symptoms of chronic venous insufficiency of the lower limbs, defined by the 100mm visual scale performed by the patient between 20mm and 60mm in the most symptomatic lower limb.

• For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.

• Patient read, understood, signed and dated the free and informed consent form

Locations
Other Locations
Brazil
Centro Universitário Serra dos Órgãos - UNIFESO
RECRUITING
Teresópolis
Contact Information
Primary
Carlos Nunes, Professor
cprrnns@gmail.com
552126417088
Backup
Romualdo Gama, Professor
romualdobarbozagama@gmail.com
552126417088
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2025-02-11
Participants
Target number of participants: 120
Treatments
Experimental: Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina
Aesculus hippocastanum 50mg, Polygonum acre 10mg, Smilax Pepyracea 40mg, Rutina 20mg
Active_comparator: Diosmina, and Hesperidina
Diosmina 450mg e Hesperidina 50mg
Related Therapeutic Areas
Sponsors
Leads: Fundação Educacional Serra dos Órgãos

This content was sourced from clinicaltrials.gov