Clinical TrialID 2387

Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency

NCT03471910

Venous Insufficiency

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Record Fields

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Clinical Trial Id
2387
Evidence Id
2387
Core Evidence Id
2387
Source Clinical Trial Id
2364
Herb2 Clinical Trial Id
HBCT002364
Nct Id
NCT03471910
Title
Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency
Status
Completed
Phase
Phase 4
Study Result
No
Study Condition
Venous Insufficiency
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Diosmin|DRUG: Diosmin / Hesperidin
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
120
Outcome Measure
Change in VAS symptom scores, Change between the 100mm visual analog scale (VAS) symptoms (from 0mm \[absence of venous symptoms\] to 100mm \[maximal intensity of venous symptoms\] scores at month 0 (pretreatment) and month 6 / end of study visit (early withdrawal)., From pretreatment (month 0) until month 6 of the 6-month treatment period
Sponsor Collaborator
Fundação Educacional Serra dos Órgãos
Funded By
OTHER
Location
Centro Universitário Serra dos Órgãos - UNIFESO, Teresópolis, RJ, 25964004, Brazil
Other Id
DIVC-01-12-17
Start Date
2017-06-20
Primary Completion Date
2018-03-20
Completion Date
2018-04-30
First Posted
2018-03-21
Results First Posted
Last Update Posted
2018-06-20
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03471910
Title Cn
Title En
Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency
Bilingual Status
semi_complete