A Phase 4 interventional study of Diosmin and Diosmin / Hesperidin in Venous Insufficiency, sponsored by Fundação Educacional Serra dos Órgãos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.
The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.
The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:
Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:
The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.
162 studies on the registry are indexed under Venous Insufficiency; 14 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 127 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Fundação Educacional Serra dos Órgãos is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diosmin 600mg, one tablet once daily
Drug: Diosmin
Diosmin 900mg + Hesperidin 100mg, one tablet once daily
Drug: Diosmin / Hesperidin
Diosmin 600mg tablet, once daily
Drug pages: Diosmin · Hesperidin
Diosmin 900 mg / Hesperidin 100mg tablet, once daily
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).
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Efficacy: Evolution of VAS score at each visit
Evolution of the 100mm VAS symptoms (from 0mm \[absence of venous symptoms\] to 100mm \[maximal intensity of venous symptoms\]) at each visit
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Efficacy: Patient global satisfaction at each visit
Evaluation of the patient's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Oral acceptability
Evaluation of the oral acceptability on a 100mm VAS (from 0mm - very easy to swallow to 100mm - very difficult to swallow) of the treatment at each visit
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Tolerance: Number of related adverse events during the study
Number of related adverse events during the study
Time frame: Throughout the 6-month treatment period
Efficacy: Investigator's global satisfaction at each visit
Evaluation of the investigator's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Plan to share: No
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diosmin
Fundação Educacional Serra dos Órgãos