Efficacy and Tolerability of the Use of Varicell Compared With Daflon

NCT ID: NCT01321619

Last Updated: 2011-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

Brief 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.

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.

Conditions

Chronic Venous Insufficiency; Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Varicell

Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.

Group Type: EXPERIMENTAL

Daflon

Intervention Type: DRUG

Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.

Placebo daflon (Drug D)

Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.

Group Type: EXPERIMENTAL

Varicell placebo

Intervention Type: DRUG

Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.

Interventions

Daflon

Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Diosmin; keratin; Circanetten.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vidfarma Indústria de Medicamentos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Industry

Principal Investigators

Jacques Waisberg, Investigator

Role: PRINCIPAL_INVESTIGATOR

ABC School of Medicine

Walter Campos Júnior, Investigator

Role: PRINCIPAL_INVESTIGATOR

Edmundo Vasconcelos Hospital Teacher

Laércio Robles, Investigator

Role: PRINCIPAL_INVESTIGATOR

Santa Marcelina Hospital

Locations

Santa Marcelina Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Marcelo Calil, Investigator

Role: CONTACT

mcburihan@osite.com.br

55 11 5549-6488

Mônica Gonçalves, Coordenator

Role: CONTACT

monica_monica0001@hotmail.com

55 11 2070-6238

Facility Contacts

Marcelo Calil, Investigator

Role: primary

mcburihan@osite.com.br

55 11 2070-6238

Mônica Gonçalves, Coordenator

Role: backup

monica_monica0001@hotmail.com

55 11 2070-6238

Other Identifiers

VID-VAR-01/11

Identifier Type: -

Identifier Source: org_study_id