HaemorrhoidsDEMAND HDNCT07647172
Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions
An observational study of Haemorrhoids, run by Servier Russia at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoids
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jun 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with haemorrhoids undergoing minimally invasive surgical interventions
Who may be able to join
- 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);
Show all 11Show fewer
- 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).*
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Haemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (14)
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)
Measured: 14 days
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)
Measured: 25 days
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.
Measured: 7 days
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.
Measured: 14 days
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.
Measured: 25 days
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.
Measured: 7 days
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.
Measured: 14 days
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.
Measured: 25 days
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.
Measured: 7 days
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.
Measured: 14 days
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.
Measured: 25 days
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.
Measured: 7 days
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.
Measured: 14 days
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.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start30 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan KOSTAREV, Principal investigator, A.N. Ryzhikh National Medical Research Center of Proctology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647172
- Sponsor's protocol ID
- IC4-05682-083-RUS
- Acronym
- DEMAND HD
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07647172
- Acronym / sponsor ID
- DEMAND HD / IC4-05682-083-RUS
- Conditions
- Haemorrhoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with haemorrhoids undergoing minimally invasive surgical interventions
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
Time frame: 7 days
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)
14 secondary outcomes
Pain syndrome - Spontaneous pain(1)
Time frame: 14 days
Pain syndrome - Spontaneous pain (2)
Time frame: 25 days
Use of analgesics
Time frame: 7 days
Use of analgesics
Time frame: 14 days
Use of analgesics
Time frame: 25 days
Bleeding (1)
Time frame: 7 days
Bleeding (2)
Time frame: 14 days
Bleeding (3)
Time frame: 25 days
Perianal edema (1)
Time frame: 7 days
Perianal edema (2)
Time frame: 14 days
Perianal edema (3)
Time frame: 25 days
Pain syndrome - Pain related to defecation (1)
Time frame: 7 days
Pain syndrome - Pain related to defecation (2)
Time frame: 14 days
Pain syndrome - Pain related to defecation (3)
Time frame: 25 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan KOSTAREV principal investigator
A.N. Ryzhikh National Medical Research Center of Proctology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoids, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OLGA LINNIK (495 9370700, olga.linnik@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.