Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency

Launched by SUNWAVE PHARMA · Oct 6, 2016

Keywords

ClinConnect Summary

A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients, male or females aged 18 to 75 years old
• • BMI≤40
• • Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
• • Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
• • Willing and able to give written informed consent prior to participation in the trial
• • Patients expected to be compliant with the study treatment
• Exclusion Criteria:
• • Known allergy to the product's ingredients
• • Pregnancy or breastfeeding
• • Patient is involved in any other clinical trial
• • Deep vein thrombosis
• • Stasis dermatitis
• • The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
• • Open ulcers or lower extremity amputation
• • Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
• • Patient presenting permanent oedema,
• • Patient with a history of lower limbs trauma responsible for sequel pains
• • NYHA III and IV Heart Failure
• • Renal Failure
• • Untreated or uncontrolled Arterial Hypertension
• • Hepatic Failure
• • History of a known liver disease such as hepatitis A, hepatitis B, or C.
• • Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years
• • Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol.
• • Immobility.