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Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency

NCT03471910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-06-20

No results posted yet for this study

Summary

Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.

Conditions

  • Venous Insufficiency

Interventions

DRUG

Diosmin

Diosmin 600mg tablet, once daily

DRUG

Diosmin / Hesperidin

Diosmin 900 mg / Hesperidin 100mg tablet, once daily

Sponsors & Collaborators

  • Fundação Educacional Serra dos Órgãos

    lead OTHER

Principal Investigators

  • Marcio Steinbruch, MD · Hospital Albert Einstein

  • Renato Kaufman, MD · Universidade Estadual do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2018-03-20
Completion
2018-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471910 on ClinicalTrials.gov