- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321619
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05016-081
- Santa Marcelina Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Other Names:
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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.
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Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Other Names:
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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.
Time Frame: 30 days
|
Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
|
30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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30 days
|
Collaborators and Investigators
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
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VID-VAR-01/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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