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

Chronic Venous Insufficiency Clinical Trial

— EVELINE  

Official title:

A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02927483
• Other study ID #: OPSUN/0116/FS
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 6, 2016
• Last updated: October 27, 2016
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: SunWave Pharma
• Contact: Dionisio Barattini, MD
• Phone: +39 335 5437574
• Email: barattini[@]operacro.com
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Dietary Supplement:
• Endolex Forte®
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
• A combination of diosmin and hesperidin
A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SunWave Pharma	Opera Contract Research Organization SRL

References & Publications (7)

Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. Review. — View Citation

Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. Review. — View Citation

Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. — View Citation

Perrin M, Ramelet AA. Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):117-25. doi: 10.1016/j.ejvs.2010.09.025. Epub 2010 Dec 3. Review. — View Citation

Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995 Apr;21(4):635-45. — View Citation

Rabe E, Stücker M, Ottillinger B. Water displacement leg volumetry in clinical studies--a discussion of error sources. BMC Med Res Methodol. 2010 Jan 13;10:5. doi: 10.1186/1471-2288-10-5. Review. — View Citation

Sezer A, Usta U, Kocak Z, Yagci MA. The effect of a flavonoid fractions diosmin + hesperidin on radiation-induced acute proctitis in a rat model. J Cancer Res Ther. 2011 Apr-Jun;7(2):152-6. doi: 10.4103/0973-1482.82927. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in limb volume determination at day 180 (water displacement method)		180 days	No
Secondary	Change from baseline in limb volume determination at day 90 (water displacement method)		90 days	No
Secondary	Change from pre-treatment (baseline) in the calf circumference on treatment day 30		30 days	No
Secondary	Change from pre-treatment (baseline) in the calf circumference on treatment day 180		180 days	No
Secondary	Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90		90 days	No
Secondary	Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180		180 days	No
Secondary	Global assessment of efficacy by the investigator at day 180		180 days	No
Secondary	Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)		180 days	No
Secondary	Global assessment of tolerability by the investigator at day 180		180 days	Yes
Secondary	Adverse events		180 days	Yes