Efficacy and Tolerability of the Use of Varicell Compared With Daflon

NCT01321619 | Unknown Phase 3 DMC

• 1 other identifier: VID-VAR-01/11
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency; Hemorrhoids

Keywords

Chronic venous insufficiency; Hemorrhoidal syndrome; Varicell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.

  30 days

Study Arms (2)

Varicell

EXPERIMENTAL

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

Drug: Daflon

Placebo daflon (Drug D)

EXPERIMENTAL

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

Drug: Varicell placebo

Interventions

Daflon DRUG

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

Also known as: Diosmin

Varicell

Varicell placebo DRUG

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

Also known as: keratin, Circanetten.

Placebo daflon (Drug D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vidfarma Indústria de Medicamentos Ltda.: lead

Study Sites (1)

Santa Marcelina Hospital

São Paulo, São Paulo, 05016-081, Brazil

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Diosmin; Keratins

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Intermediate Filament Proteins; Biopolymers; Polymers; Macromolecular Substances; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Scleroproteins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo Calil, Investigator

CONTACT

55 11 5549-6488; mcburihan@osite.com.br

Mônica Gonçalves, Coordenator

CONTACT

55 11 2070-6238; monica_monica0001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 23, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

BR (1)