Clinical trial NCT01321619: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Venous Insufficiency
Hemorrhoids
Keywords: Chronic venous insufficiency
Hemorrhoidal syndrome
Varicell
Lead sponsor: Vidfarma Indústria de Medicamentos Ltda.
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
timeFrame: 30 days
Secondary outcomes:
measure: Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Marcelina Hospital
Study officials:
affiliation: ABC School of Medicine
name: Jacques Waisberg, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Edmundo Vasconcelos Hospital Teacher
name: Walter Campos Júnior, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Marcelina Hospital
name: Laércio Robles, Investigator
role: PRINCIPAL_INVESTIGATOR
References: