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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Varicell
Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Intervention: Daflon (Drug)
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: Varicell placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.(30 days)