Hemorrhoidal DiseaseVIVI2022/01NCT07376928
Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade
An observational study of Hemorrhoidal Disease, run by Italfarmaco at 1 site in Italy.
Trial summary
Hemorrhoidal disease is one of the most common proctologic disease. This condition affects a large number of people in the world: the prevalence can vary from 4.4% in the general population to 36.4% in general practice [1]. It usually appears with symptoms and signs of bleeding, prolapse, soiling, itching, and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidal Disease
- What is being tested?
- Phlebotonic
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- 5 Apr 2023to 28 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade
Who may be able to join
- Capable of giving signed informed consent allowing data collection in accordance with local requirements;
- Males or females aged ≥ 18 years;
- Patients with symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade;
- Patients who are going to start treatment with phlebotonics, according to the clinical practice and according to the approved indications as described in the current version of the SmPC (Summary of Product Characteristics) approved in Italy. Patients are considered includible both in case never used phlebotonics or have stopped using phlebotonics for at least one month.
Who cannot join
- Presence of concomitant, severe systemic disorders;
- Hypersensitivity to the active ingredients of products under observation, or to one or more excipients present in the products under observation or known hypersensitivity to any other product containing the same active ingredients or excipients;
- History of Colorectal or anal cancer and/or radiotherapy; obstructive defecation syndrome; irritable bowel syndrome; inflammatory bowel disease; coagulation disorders; other proctologic diseases, such as anal abscess or fistula; anal fissure or acute hemorrhoidal thrombosis; and anticoagulant or anti-aggregant intake for another disease;
- Women who are known to be pregnant or breastfeeding;
- Current participation in another trial is not permitted unless it is a non-interventional study, and the sole purpose of the trial is for long-term follow up describing clinical features or survival data (registry).
Trial locations and contacts
1 site in 1 country.
About this study
Hemorrhoidal disease is one of the most common proctologic disease. This condition affects a large number of people in the world: the prevalence can vary from 4.4% in the general population to 36.4% in general practice [1]. It usually appears with symptoms and signs of bleeding, prolapse, soiling, itching, and pain. Bleeding is the most relevant and frequent symptom, reported by 56-81% of the patients; this sign is the most important reason for which most of patients are worried and they decide to be subjected to proctologic examination.
Medical and conservative management (life style changes, high-fiber diets, stool softeners, laxatives, and sitz baths are treatments chosen in hemorrhoidal disease from Goligher's I to III grade.
Read more
Hemorrhoidal disease (HD) has a significative incidence accounting for a large number of consultation per year and a large number of ambulatory or surgical treatments. Early symptoms are often treated tempirically with self prescription and OTC (over-the-counter) products with in spite of the value of different substances available.
In addition, symptoms such as tenesmus, mucus secretion or intense anal pain, if frequent and intense, significantly worsen the patient's quality of life and therefore require particular attention Phlebotonics are heterogeneous and widely investigated classes of drugs used to treat hemorrhoidal disease, with the aim to obtain strengthening of blood vessel walls, increasing venous tone, lymphatic drainage, normalizing capillary permeability, and anti-inflammatory effects.
Scientific production includes research on individual active ingredients but also on products that exploit the synergy of multiple active ingredients. Furthermore, the use of flavonoids is being analyzed both as an alternative to surgery, both in preparation and after the surgery itself.
- Conditions
- Hemorrhoidal Disease
- Being tested
- Phlebotonic
- Keywords
- Goligher grade I, Goligher grade II, Goligher grade III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotonicDrug
Phlebotonics treatment will be used
| Study group | Role | What they receive |
|---|---|---|
| 1 | Phlebotonics Receives: Drug: Phlebotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline characteristics of this italian real-world cohort
The primary endpoint has been evaluated using HDSS-Hemorrhoidal disease symptoms score by Rorvik.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Apr 2023
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoidal DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376928
- Sponsor's protocol ID
- VIVI2022/01
- Acronym
- VIVI2022/01
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giani I, Leopardi F, Bonetti T, Pietroletti R, Gallo G, Tersigni L, Tanasi E, Piazza R, Mangrella M, Elbetti C. Evaluating the effectiveness of oral phlebotonics for the conservative management of hemorrhoidal disease: insights from the VIVI2022/01/VIVALDI study. Front Surg. 2026 May 12;13:1771489. doi: 10.3389/fsurg.2026.1771489. eCollection 2026.
PubMed 42205186
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade
- ClinicalTrials.gov ID
- NCT07376928
- Acronym / sponsor ID
- VIVI2022/01 / VIVI2022/01
- Conditions
- Hemorrhoidal Disease
- Keywords
- Goligher grade I, Goligher grade II, Goligher grade III
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 29 Jan 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.
Hemorrhoidal disease is one of the most common proctologic disease. This condition affects a large number of people in the world: the prevalence can vary from 4.4% in the general population to 36.4% in general practice [1]. It usually appears with symptoms and signs of bleeding, prolapse, soiling, itching, and pain. Bleeding is the most relevant and frequent symptom, reported by 56-81% of the patients; this sign is the most important reason for which most of patients are worried and they decide to be subjected to proctologic examination.
Medical and conservative management (life style changes, high-fiber diets, stool softeners, laxatives, and sitz baths are treatments chosen in hemorrhoidal disease from Goligher's I to III grade.
Hemorrhoidal disease (HD) has a significative incidence accounting for a large number of consultation per year and a large number of ambulatory or surgical treatments. Early symptoms are often treated tempirically with self prescription and OTC (over-the-counter) products with in spite of the value of different substances available.
In addition, symptoms such as tenesmus, mucus secretion or intense anal pain, if frequent and intense, significantly worsen the patient's quality of life and therefore require particular attention Phlebotonics are heterogeneous and widely investigated classes of drugs used to treat hemorrhoidal disease, with the aim to obtain strengthening of blood vessel walls, increasing venous tone, lymphatic drainage, normalizing capillary permeability, and anti-inflammatory effects.
Scientific production includes research on individual active ingredients but also on products that exploit the synergy of multiple active ingredients. Furthermore, the use of flavonoids is being analyzed both as an alternative to surgery, both in preparation and after the surgery itself.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: PhlebotonicPhlebotonics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade
Key inclusion criteria (4 listed)
- Capable of giving signed informed consent allowing data collection in accordance with local requirements;
- Males or females aged ≥ 18 years;
- Patients with symptomatic hemorrhoidal disease (HD) of I, II or III Goligher grade;
- Patients who are going to start treatment with phlebotonics, according to the clinical practice and according to the approved indications as described in the current version of the SmPC (Summary of Product Characteristics) approved in Italy. Patients are considered includible both in case never used phlebotonics or have stopped using phlebotonics for at least one month.
Key exclusion criteria (5 listed)
- Presence of concomitant, severe systemic disorders;
- Hypersensitivity to the active ingredients of products under observation, or to one or more excipients present in the products under observation or known hypersensitivity to any other product containing the same active ingredients or excipients;
- History of Colorectal or anal cancer and/or radiotherapy; obstructive defecation syndrome; irritable bowel syndrome; inflammatory bowel disease; coagulation disorders; other proctologic diseases, such as anal abscess or fistula; anal fissure or acute hemorrhoidal thrombosis; and anticoagulant or anti-aggregant intake for another disease;
- Women who are known to be pregnant or breastfeeding;
- Current participation in another trial is not permitted unless it is a non-interventional study, and the sole purpose of the trial is for long-term follow up describing clinical features or survival data (registry).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotonicPhlebotonics treatment will be used | Drug | 1 |
Primary outcome
The baseline characteristics of this italian real-world cohort
Time frame: 36 months
The primary endpoint has been evaluated using HDSS-Hemorrhoidal disease symptoms score by Rorvik.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 42205186Giani I, Leopardi F, Bonetti T, Pietroletti R, Gallo G, Tersigni L, Tanasi E, Piazza R, Mangrella M, Elbetti C. Evaluating the effectiveness of oral phlebotonics for the conservative management of hemorrhoidal disease: insights from the VIVI2022/01/VIVALDI study. Front Surg. 2026 May 12;13:1771489. doi: 10.3389/fsurg.2026.1771489. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemorrhoidal Disease, run by Italfarmaco at 1 site in Italy.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jan 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline characteristics of this italian real-world cohort (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376928, which also lists 1 linked publication.
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 29 Jan 2026.