Efficacy and Tolerability of the Use of Varicell Compared With Daflon

Last updated: June 13, 2011
Sponsor: Vidfarma Indústria de Medicamentos Ltda.
Overall Status: Trial Status Unknown

Phase

3

Condition

Vascular Diseases

Varicose Veins

Venous Thrombosis

Treatment

N/A

Clinical Study ID

NCT01321619
VID-VAR-01/11
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For both groups

  • Patients who consent to participate in the study by signing the Instrument of Consent.

  • Patients of all ethnic groups, of both sexes and aged at least 18 years old andmaximum 65 years old;

  • Being for seven days without any medication or treatment related to the venous system.

  • Patients able to make proper use of medication; For Group V - Chronic Venous Insufficiency.

  • Presence of at least two symptoms (pain, heaviness and discomfort) in the lower limbswith scores greater than 3 measured by visual analogue scale;

  • Clinical diagnosis of varicose veins rating of 0 to 3 by CEAP; In Group H - hemorrhoidal syndrome.

  • Presence of at least two symptoms (pain in the anorectal evacuation to walk and / orat rest, feeling of anal discomfort (burning, itching, irritation) to evacuate to walkand / or at rest, bloating in the anorectal region, the presence and intensity ofbleeding in the anorectal region, the presence and intensity of mucus in the anorectalregion) with a score equal to or greater than 3 measured by visual analogue scale;

  • Clinical Diagnosis of Hemorrhoids grade 1 and grade 2.

Exclusion

Exclusion Criteria: Pregnant or lactating;

  • Patients aged less than 18 years old or older than 65 years old;

  • Patients with a history of hypersensitivity to any component of the formula;

  • Use of medications phlebotonics in the last 7 days;

  • previous venous surgery;

  • Patients with renal and liver failure.

  • Patients with gastritis or gastric ulcer;

  • Patients with acute inflammatory diseases of the bowel, intestinal obstruction,appendicitis;

  • Patients with ileus, stenosis, atony, undiagnosed abdominal symptoms, colonopathyinflammatory abdominal pain of unknown cause dehydration and loss of water andelectrolytes and constipation;

  • Patients with blood coagulation disorders;

  • Any condition which in the opinion of the physician investigator is significant andcan make the patient unsuitable for study or that might put you under additional risk.

Study Design

Total Participants: 102
Study Start date:
July 01, 2011
Estimated Completion Date:
December 31, 2011

Study Description

To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

Connect with a study center

  • Santa Marcelina Hospital

    São Paulo, 05016-081
    Brazil

    Site Not Available

  • Santa Marcelina Hospital

    São Paulo, 05016-081
    Brazil

    Site Not Available

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