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RecruitingNCT07647172DEMAND HDUpdated Sep 24, 2026

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

An observational study in Haemorrhoids, sponsored by Servier Russia. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Servier Russia · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This observational program does not imply changes to the common treatment strategy in patients with chronic hemorrhoids. In this observational study, the parameters usually assessed during the examination of patients with grade 2 or 3 chronic hemorrhoids, according to the Goligher classification, will be recorded The observational design of the program assumes that all examinations, procedures and changes to the patient's therapy, including changes in the doses of medications, should be carried out only per decision of the attending physician and in full accordance with existing guidelines for the management of patients of the analysed category, instructions for the medical use of a medicinal product and within the established routine practice.

02

Conditions studied

  • Haemorrhoids

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03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 200 is above the median of 151 across 49 observational studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Servier Russia is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with haemorrhoids undergoing minimally invasive surgical interventions

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).*

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breast-feeding, or planning for pregnancy during the study or at least in two months after its completion.
  • Confirmed or suspected .
  • Severe somatic disorder (of heart or blood vessels, lungs, kidneys, pancreas, or liver), accompanied by the organ function decompensation.
  • Mental disorder.
  • 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).
Terms in these criteria, in plain language(2)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group N 1

    This study is non-interventional and has an observational nature, so randomization is not provided for it. This protocol will use the approach with random allocation of sites into clusters depending on the postoperative treatment strategy, acceptable for an observational study. In order to maintain a balance between the number of patients receiving MPFF and those not receiving any systemic venoactive drug, a random distribution of research sites into two clusters will be performed by compiling a table identical to the randomization tables for clinical trials. The study sites allocated to the first cluster will recruit patients who meet the criteria for the group N 1 - those with planned prescription and use of MPFF after the minimally invasive surgical intervention

  • Group N 2

    The study sites allocated to the second cluster will recruit patients who meet the criteria for the group 2 - those without the planned prescription of any systemic venoactive drugs after the minimally invasive surgical intervention

06

What researchers measure

Primary outcomes

  1. The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)

    The change in the pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS) on day 7 after the intervention as compared with the baseline value at the V0 visit. visual analogue scale (VAS). a 100 mm long scale, in which the 0 mm point corresponds to the absence of pain (minimum value) and the 100 mm point to maximum, unbearable pain (maximum values)

    Time frame: 7 days

Secondary outcomes

  1. Pain syndrome - Spontaneous pain(1)

    The change in the pain syndrome severity score (spontaneous pain) of VAS on day 14 after the intervention as compared with the baseline value at the V0 visit. visual analogue scale (VAS). a 100 mm long scale, in which the 0 mm point corresponds to the absence of pain (minimum value) and the 100 mm point to maximum, unbearable pain (maximum values)

    Time frame: 14 days

  2. Pain syndrome - Spontaneous pain (2)

    The change in the pain syndrome severity score (spontaneous pain) of VAS on day 25 after the intervention as compared with the baseline value at the V0 visit. visual analogue scale (VAS). a 100 mm long scale, in which the 0 mm point corresponds to the absence of pain (minimum value) and the 100 mm point to maximum, unbearable pain (maximum values)

    Time frame: 25 days

  3. Use of analgesics

    The proportion (%) of patients continuing to take analgesics on days 7 after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 7 days

  4. Use of analgesics

    The proportion (%) of patients continuing to take analgesics on days 14 after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 14 days

  5. Use of analgesics

    The proportion (%) of patients continuing to take analgesics on days 25 after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 25 days

  6. Bleeding (1)

    Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 7 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 7 days

  7. Bleeding (2)

    Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 14 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 14 days

  8. Bleeding (3)

    Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 25 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 25 days

  9. Perianal edema (1)

    Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 7 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 7 days

  10. Perianal edema (2)

    Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 14 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 14 days

  11. Perianal edema (3)

    Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 25 day after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 25 days

  12. Pain syndrome - Pain related to defecation (1)

    The change in the pain syndrome severity score (pain related to defecation) of VAS on day 7 after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 7 days

  13. Pain syndrome - Pain related to defecation (2)

    The change in the pain syndrome severity score (pain related to defecation) of VAS on day 14 after the intervention as compared with the baseline value at the V0 visit.

    Time frame: 14 days

  14. Pain syndrome - Pain related to defecation (3)

    The change in the pain syndrome severity score (pain related to defecation) of VAS on day 25 after the intervention as compared with the baseline score at the V0 visit.

    Time frame: 25 days

07

Study locations

1 of 1 sites recruiting
  • GBUZ hospital
    Moscow, Russia
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.

Of 27 observational studies under Hemorrhoids, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2026
First posted
Jun 15, 2026
StartActual
Jun 30, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Apr 1, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07647172
Lead sponsor
Servier Russia
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Jun 30, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

OLGA LINNIK
Contact
olga.linnik@servier.com
495 9370700
Ivan KOSTAREV
principal investigator · A.N. Ryzhikh National Medical Research Center of Proctology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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