Efficacy and Tolerability of the Use of Varicell Compared With Daflon

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Vidfarma Indústria de Medicamentos Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Vidfarma Indústria de Medicamentos Ltda.
ClinicalTrials.gov Identifier:
NCT01321619
First received: March 15, 2011
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Chronic Venous Insufficiency
Hemorrhoids
Drug: Daflon
Drug: Varicell placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vidfarma Indústria de Medicamentos Ltda.:

Primary Outcome Measures:
  • Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.


Secondary Outcome Measures:
  • Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.


Estimated Enrollment: 102
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321619

Contacts
Contact: Marcelo Calil, Investigator 55 11 5549-6488 mcburihan@osite.com.br
Contact: Mônica Gonçalves, Coordenator 55 11 2070-6238 monica_monica0001@hotmail.com

Locations
Brazil
Santa Marcelina Hospital Not yet recruiting
São Paulo, Brazil, 05016-081
Contact: Marcelo Calil, Investigator    55 11 2070-6238    mcburihan@osite.com.br   
Contact: Mônica Gonçalves, Coordenator    55 11 2070-6238    monica_monica0001@hotmail.com   
Sub-Investigator: Walter Campos Junior, Investigator         
Sub-Investigator: Laércio Robles, Investigator         
Sub-Investigator: Jacques Waisberg, Investigator         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Vidfarma Indústria de Medicamentos Ltda., Industry
ClinicalTrials.gov Identifier: NCT01321619     History of Changes
Other Study ID Numbers: VID-VAR-01/11
Study First Received: March 15, 2011
Last Updated: June 13, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Vidfarma Indústria de Medicamentos Ltda.:
Chronic venous insufficiency
Hemorrhoidal syndrome
Varicell

Additional relevant MeSH terms:
Hemorrhoids
Venous Insufficiency
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014