Hemorrhoidal disease Circulatory System Haemorrhoids
Conditions
Interventions
All participants will receive 3 g/day of MPFF during 4 days and 2 g/day of MPFF during the 3 following days. Participants will be randomly allocated to receive this dose in the form of either 500 mg t
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 18 to 75 years old (inclusive) 2. Out-patient 3. Suffering from acute and non-complicated hemorrhoidal episode (acute pain with oedema assessed by a Visual Analog Scale and/or bleeding assessed by a 4-point scale)
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding or possibility of becoming pregnant 2. Complicated hemorrhoidal disease (requiring surgery, stage IV prolapsed hemorrhoids, anal fissure, associated infection), patients presenting other anal bleeding pathologies 3. Laser therapy, anal surgery, canal radiation before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (clinical acceptability) assessed at each visit (day 0, day 7, day 14). Safety assessment takes into account adverse events, weight, sitting blood pressure and heart rate, bleeding cessation evaluation by a 4-point scale, pain evaluation by Visual Analog Scale and laboratory examination | — |
Countries
Russian Federation, Serbia
Outcome results
None listed