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Efficacy and Tolerability of the Use of Varicell Compared With Daflon

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ClinicalTrials.gov Identifier: NCT01321619
Recruitment Status : Unknown
Verified June 2011 by Vidfarma Indústria de Medicamentos Ltda..
Recruitment status was:  Not yet recruiting
First Posted : March 23, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Vidfarma Indústria de Medicamentos Ltda.

Tracking Information
First Submitted Date  ICMJE March 15, 2011
First Posted Date  ICMJE March 23, 2011
Last Update Posted Date June 14, 2011
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ]
Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01321619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ]
Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of the Use of Varicell Compared With Daflon
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Venous Insufficiency
  • Hemorrhoids
Intervention  ICMJE
  • Drug: Daflon
    Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
    Other Name: Diosmin
  • 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.
Study Arms  ICMJE
  • Experimental: Varicell
    Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
    Intervention: Drug: Daflon
  • 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.
    Intervention: Drug: Varicell placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 22, 2011)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321619
Other Study ID Numbers  ICMJE VID-VAR-01/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vidfarma Indústria de Medicamentos Ltda., Industry
Study Sponsor  ICMJE Vidfarma Indústria de Medicamentos Ltda.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Vidfarma Indústria de Medicamentos Ltda.
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP