Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency
NCT ID: NCT02927483
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2016-11-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endolex Forte®
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Opera CRO, a TIGERMED Group Company
OTHER
SunWave Pharma
OTHER
Responsible Party
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Principal Investigators
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Calin Giurcaneanu, MD
Role: PRINCIPAL_INVESTIGATOR
Spitalul Universitar de Urgenta Elias, Sectia Dermatologie
Central Contacts
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References
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Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
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. doi: 10.1177/1358836X9900400101.
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. doi: 10.1016/s0741-5214(95)70195-8.
Rabe E, Stucker 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.
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.
Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available.
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.
Other Identifiers
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OPSUN/0116/FS
Identifier Type: -
Identifier Source: org_study_id