Efficacy and Tolerability of the Use of Varicell Compared With Daflon
Primary Purpose
Chronic Venous Insufficiency, Hemorrhoids
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Daflon
Varicell placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring Chronic venous insufficiency, Hemorrhoidal syndrome, Varicell
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.
Sites / Locations
- Santa Marcelina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Varicell
Placebo daflon (Drug D)
Arm Description
Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.
Full Information
NCT ID
NCT01321619
First Posted
March 15, 2011
Last Updated
June 13, 2011
Sponsor
Vidfarma Indústria de Medicamentos Ltda.
1. Study Identification
Unique Protocol Identification Number
NCT01321619
Brief Title
Efficacy and Tolerability of the Use of Varicell Compared With Daflon
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Vidfarma Indústria de Medicamentos Ltda.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, Hemorrhoids
Keywords
Chronic venous insufficiency, Hemorrhoidal syndrome, Varicell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Varicell
Arm Type
Experimental
Arm Description
Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Arm Title
Placebo daflon (Drug D)
Arm Type
Experimental
Arm Description
Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Intervention Type
Drug
Intervention Name(s)
Daflon
Other Intervention Name(s)
Diosmin
Intervention Description
Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Intervention Type
Drug
Intervention Name(s)
Varicell placebo
Other Intervention Name(s)
keratin, Circanetten.
Intervention Description
Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Primary Outcome Measure Information:
Title
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Description
Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Description
Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Calil, Investigator
Phone
55 11 5549-6488
Email
mcburihan@osite.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mônica Gonçalves, Coordenator
Phone
55 11 2070-6238
Email
monica_monica0001@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Waisberg, Investigator
Organizational Affiliation
ABC School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Campos Júnior, Investigator
Organizational Affiliation
Edmundo Vasconcelos Hospital Teacher
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laércio Robles, Investigator
Organizational Affiliation
Santa Marcelina Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Marcelina Hospital
City
São Paulo
ZIP/Postal Code
05016-081
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Calil, Investigator
Phone
55 11 2070-6238
Email
mcburihan@osite.com.br
First Name & Middle Initial & Last Name & Degree
Mônica Gonçalves, Coordenator
Phone
55 11 2070-6238
Email
monica_monica0001@hotmail.com
First Name & Middle Initial & Last Name & Degree
Walter Campos Junior, Investigator
First Name & Middle Initial & Last Name & Degree
Laércio Robles, Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Waisberg, Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerability of the Use of Varicell Compared With Daflon
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