Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions

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Conditions studied: Haemorrhoids

In brief

Evaluation of the effectiveness of micronized purified flavonoid fraction (MPFF) as part of the conservative therapy and impact on quality of life and satisfaction with treatment in the real-life clinical practice in patients with haemorrhoids undergoing minimally invasive surgical interventions

Key facts

Study ID

NCT07647172

Run by

Servier Russia

People needed

200

Starts

2026-07-01

Expected to finish

2027-04-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged over 18 years.
• Informing the patient in writing about the inclusion in the study and his/her consent to participate in it.
• Absence of conditions requiring urgent medical care.
• The patient was diagnosed with chronic hemorrhoids of grade 2 or 3 according to Goligher classification.
• The patient is scheduled to undergo one of the listed types of minimally invasive surgical treatment within 7 ± 2 days from the inclusion in the study (V0):
• laser vaporization (laser submucosal destruction or ablation);
• transanal dearterialization (hemorrhoidal artery ligation);
• transanal dearterialization + laser vaporization (laser submucosal destruction or ablation);
• transanal dearterialization + sclerotherapy.
• No venoactive drug treatment within 4 weeks prior to inclusion in the study.
• The patient has been prescribed with MPFF at the inclusion visit, or it is planned to prescribe MPFF-containing drug in the postoperative period (for cluster 1 sites), or the patient has not been prescribed with any systemic venoactive drug, and it is not planned to prescribe it the postoperative period (for cluster 2 sites).*

You may not qualify if…

• Pregnancy or breast-feeding, or planning for pregnancy during the study or at least in two months after its completion.
• Confirmed or suspected malignancy.
• Severe somatic disorder (of heart or blood vessels, lungs, kidneys, pancreas, or liver), accompanied by the organ function decompensation.
• Mental disorder.
• Contraindications for examination.
• Predicted unwillingness of the patient to follow the protocol of treatment and supervision, poor adherence to treatment.
• Patient's participation in any interventional/observational study at the present time.
• Patients who received venoactive drugs in the 4 weeks prior to Visit 0 (inclusion visit).

Full record on ClinicalTrials.gov

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