Efficacy and Tolerability of the Use of Varicell Compared With Daflon

Study Clinical, Multicenter,Phase III,Prospective,Randomized,Comparative Double Blind/Double-dummy to Assess the Efficacy and Tolerability of the Use of Varicell in Reducing the Symptoms Caused by Chronic Venous Insufficiency and Hemorrhoidal Syndrome When Compared With Daflon

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids; Chronic Venous Insufficiency
• Intervention / Treatment: Drug: Daflon; Drug: Varicell placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05016-081
    • Santa Marcelina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 and maximum 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 limbs with 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 / or at rest, feeling of anal discomfort (burning, itching, irritation) to evacuate to walk and / or at rest, bloating in the anorectal region, the presence and intensity of bleeding in the anorectal region, the presence and intensity of mucus in the anorectal region) with a score equal to or greater than 3 measured by visual analogue scale;
• Clinical Diagnosis of Hemorrhoids grade 1 and grade 2.

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, colonopathy inflammatory abdominal pain of unknown cause dehydration and loss of water and electrolytes and constipation;
• Patients with blood coagulation disorders;
• Any condition which in the opinion of the physician investigator is significant and can make the patient unsuitable for study or that might put you under additional risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varicell; Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.	Drug: Daflon; Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.; Other Names: Diosmin
Experimental: Placebo daflon (Drug D); Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.	Drug: Varicell placebo; Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.; Other Names: keratin; Circanetten.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.	Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.	Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.	30 days

Collaborators and Investigators

• Sponsor: Vidfarma Indústria de Medicamentos Ltda.
• Investigators: Principal Investigator: Jacques Waisberg, Investigator, ABC School of Medicine; Principal Investigator: Walter Campos Júnior, Investigator, Edmundo Vasconcelos Hospital Teacher; Principal Investigator: Laércio Robles, Investigator, Santa Marcelina Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: March 15, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Chronic venous insufficiency; Hemorrhoidal syndrome; Varicell
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Venous Insufficiency
• Other Study ID Numbers: VID-VAR-01/11