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100% Pure Diosmin versus Micronised Purified Flavonoid Fraction in the treatment of chronic venous disease

100% Pure Diosmin versus Micronised Purified Flavonoid Fraction (MPFF) in the treatment of chronic venous disease: A Randomized Control Study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064003
Enrollment
105
Registered
2024-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

Intervention1: MPFF: Group A will be given only compression stockings. Group B will be given Compression stockings & Diosmin (venusmin) 450 mg twice daily. Group C will be given Compression stocking

Sponsors

Walter Bushnell Pharmaceuticals Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both genders between 18 and 70 years. Patient presenting a C1 to C4 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification Doppler report showing evidence of GSV, SSV or perforator reflux)

Exclusion criteria

Exclusion criteria: Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period Known allergy or hypersensitivity to any component of the study drug CEAP levels 5 & 6 Patient with venous disease requiring surgery / chemical endovenous sclerotherapy Patient suffering from a painful pathology other than the venous pain in the lower limbs Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion Patient with alteration of general condition incompatible with his / her participation in the trial Patient wishing to be pregnant in the 6 following months History of chronic drug intake, Opioid/drug addiction/alcoholism Psychiatric illness, CLD, COPD, CKD Pregnant patients or those wishing to be pregnant in the coming 6 months

Design outcomes

Primary

MeasureTime frame
Changes in Venous Clinical Severity Score (VCSS)Timepoint: Baseline After 30 Days After 60 Days After 90 Days

Secondary

MeasureTime frame
Change/decrease in venous refluxTimepoint: 1 year

Countries

India

Contacts

Public ContactAshish Dey

Sir Ganga Ram Hospital

ashishdey_78@rediffmail.com919971007627

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026