HemorrhoidPhase 4NCT07128979
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
A Phase 4 study testing Neoven 225 mg capsules in people with Hemorrhoid, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Hemorrhoidal disease is characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Neoven 225 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 2 Nov 2026
- Phase
- Phase 4
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 18-45 with complaints (symptomatic) consistent with hemorrhoidal disease
- Patients with Stage II and III hemorrhoids according to the Goligher Hemorrhoid Rating system using physical examination (digital rectal examination, anoscopy/rectoscopy performed within a maximum of four weeks before the examination)
- Patients who have signed the Informed Consent Form
Who cannot join
- Patients aged <18 and >45 years
- Stage I and IV hemorrhoids according to the Goligher Hemorrhoid Rating system
- Surgery for hemorrhoids at any time
- Injection treatment for multiple hemorrhoids in the last 3 years
- Perianal sepsis, inflammatory bowel disease, colorectal malignancy, or pre-existing sphincter injury within the last 3 years
- Immunodeficiency
- In addition to hemorrhoids, patients with anal fissures and perianal fistulas detected by simultaneous physical examination or anoscopy/rectoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdulhamid Training and Research Hospital
Istanbul
Haluk Kerim Karakullukcu, MD, +905384357181, halukkarakullukcu@gmail.com
About this study
Official title: Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids: A Randomized, Double-blind Phase IV Clinical Trial
Hemorrhoidal disease is characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. Unlike advanced stage (stage IV) hemorrhoids, which require surgical intervention, various topical agents (gels, ointments, creams), oral venoactive drugs, homeopathic and phytotherapeutic products and nutritional supplements are widely used in stage II and III hemorrhoidal disease. The genus Ruscus (family Asparagaceae) is a group of plants native to the Mediterranean basin, Southern and Western Europe, and Iran, represented by perennial, rhizome-based, and evergreen shrubs. Among the species belonging to this genus, Ruscus aculeatus L. has the widest distribution area. The subsoil parts of the Ruscus plant are rich in steroidal saponins and show vasoconstrictor, diuretic, anti-inflammatory and venotonic effects, especially with ruscogenin and neoruscogenin compounds. Due to these properties, R. aculeatus stands out as a traditional phytotherapy agent that has been used for a long time in chronic venous insufficiency. However, there are no controlled clinical studies in the literature evaluating the efficacy and safety of Ruscus aculeatus L. in hemorrhoidal disease. Therefore, this study was aimed to systematically evaluate the contribution of a phytotherapeutic product containing R. aculeatus to the treatment of stage II-III hemorrhoidal patients and to provide scientific evidence of a new and potentially safe herbal treatment option that can be used in the treatment of hemorrhoids.
Read the detailed description
The aim of this study was to evaluate the efficacy and safety of Neoven 225 mg capsule containing Ruscus aculeatus L. in individuals with stage II-III hemorrhoidal disease according to the Goligher classification.
Hemorrhoidal disease is characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. As a result, venous distension, inflammation, erosion, bleeding and thrombosis may develop in hemorrhoidal tissues.
Clinically, depending on the stage of the disease, symptoms such as bright red rectal bleeding during defecation, discomfort around the anus, itching, fecal incontinence, pain and protrusion may occur. However, uncertainty about the pharmacological treatment of hemorrhoidal disease still remains.
Unlike advanced stage (stage IV) hemorrhoids, which require surgical intervention, various topical agents (gels, ointments, creams), oral venoactive drugs, homeopathic and phytotherapeutic products and nutritional supplements are widely used in stage II and III hemorrhoidal disease. Among oral venoactive drugs, synthetic calcium dobesilate, diosmin-hesperidin combination of natural origin, triterpenes and saponins are the most well-known compounds. The genus Ruscus (family Asparagaceae) is a group of plants native to the Mediterranean basin, Southern and Western Europe, and Iran, represented by perennial, rhizome-based, and evergreen shrubs. Among the species belonging to this genus, Ruscus aculeatus L. has the widest distribution area. The subsoil parts of the Ruscus plant are rich in steroidal saponins and show vasoconstrictor, diuretic, anti-inflammatory and venotonic effects, especially with ruscogenin and neoruscogenin compounds. Due to these properties, R. aculeatus stands out as a traditional phytotherapy agent that has been used for a long time in chronic venous insufficiency.
However, there are no controlled clinical studies in the literature evaluating the efficacy and safety of Ruscus aculeatus L. in hemorrhoidal disease. Therefore, this study was aimed to systematically evaluate the contribution of a phytotherapeutic product containing R. aculeatus to the treatment of stage II-III hemorrhoidal patients and to provide scientific evidence of a new and potentially safe herbal treatment option that can be used in the treatment of hemorrhoids.
- Conditions
- Hemorrhoid
- Being tested
- Neoven 225 mg capsules, Placebo
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoven 225 mg capsulesDrug
Patients in this group will only use Neoven 225 mg capsules orally. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. A total of 378 mg of total ruscogenin (ruscogenin/neoruscogenin mixture obtained by extraction method) will be taken orally using one Neoven capsule orally with meals twice a day. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study.
PlaceboDrug
Patients in this group will only receive an oral placebo capsule designed for this study. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. During this period, one placebo capsule will be taken orally twice a day with meals. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study.
| Study group | Role | What they receive |
|---|---|---|
| Study group: Neoven 225 mg capsules | Active comparator | Patients in this group will only use Neoven 225 mg capsules orally. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. A total of 378 mg of total ruscogenin (ruscogenin/neoruscogenin mixture obtained by extraction method) will be taken orally using one Neoven capsule orally with meals twice a day. A total of 84 capsules will be given to the patients. Receives: Drug: Neoven 225 mg capsules |
| Control group | Placebo comparator | Patients in this group will only receive an oral placebo capsule designed for this study. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. During this period, one placebo capsule will be taken orally twice a day with meals. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life for HSS (Hemorrhoid Severity Score)
Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of pruritis, pain, prolapse, bleeding and soiling. All the five components in this classification system are graded into four grades ranging from 0 to 3.
Measured: At the end of the treatment (42nd day)
Secondary outcomes (2)
Hemorrhoidal Disease Symptom Score (HHSS)
The HHSS is a scale that is scored based on five main symptoms: pain, bleeding, itching, fecal incontinence, and prolapse. For the frequency rating of these symptoms, the total score is calculated according to the five-point Liekert classification [Never (score=0), Less than once a month (score=1), Less than once a week (score=2), 1-6 days a week (score=3), Every day/always (score=4)]. The total score ranges from 0 to 20.
Measured: At the end of the treatment (42nd day)
Visual Analog Scale (VAS)
A visual scale with a value range between 0 and 10 will be shown to patients for the VAS pain score, and the they will be asked to rate their current pain as "0"; for no pain and "10"; for unbearable severe pain
Measured: At the end of the treatment (42nd day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- Atabay Kimya Sanayi Ticaret A.S.
- Responsible party
- Sponsor
- Investigators
- Haluk Kerim KARAKULLUKCU, MD, Principal investigator, Sultan Abdulhamid Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128979
- Sponsor's protocol ID
- 2024-KAEK-18
- Status last verified
- Jul 2025
- First submitted
- 7 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouskela E, Cyrino FZ, Marcelon G. Effects of Ruscus extract on the internal diameter of arterioles and venules of the hamster cheek pouch microcirculation. J Cardiovasc Pharmacol. 1993 Aug;22(2):221-4. doi: 10.1097/00005344-199308000-00008.
PubMed 7692161Masullo M, Pizza C, Piacente S. Ruscus Genus: A Rich Source of Bioactive Steroidal Saponins. Planta Med. 2016 Dec;82(18):1513-1524. doi: 10.1055/s-0042-119728. Epub 2016 Nov 8.
PubMed 27825178Boyle P, Diehm C, Robertson C. Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. Int Angiol. 2003 Sep;22(3):250-62.
PubMed 14612852Pompilio G, Nicolaides A, Kakkos SK, Integlia D. Systematic literature review and network Meta-analysis of sulodexide and other drugs in chronic venous disease. Phlebology. 2021 Oct;36(9):695-709. doi: 10.1177/02683555211015020. Epub 2021 May 13.
PubMed 33983078
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids: A Randomized, Double-blind Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT07128979
- Acronym / sponsor ID
- 2024-KAEK-18
- Conditions
- Hemorrhoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Collaborators
- Atabay Kimya Sanayi Ticaret A.S.
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 19 Aug 2025 (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 characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. Unlike advanced stage (stage IV) hemorrhoids, which require surgical intervention, various topical agents (gels, ointments, creams), oral venoactive drugs, homeopathic and phytotherapeutic products and nutritional supplements are widely used in stage II and III hemorrhoidal disease. The genus Ruscus (family Asparagaceae) is a group of plants native to the Mediterranean basin, Southern and Western Europe, and Iran, represented by perennial, rhizome-based, and evergreen shrubs. Among the species belonging to this genus, Ruscus aculeatus L. has the widest distribution area. The subsoil parts of the Ruscus plant are rich in steroidal saponins and show vasoconstrictor, diuretic, anti-inflammatory and venotonic effects, especially with ruscogenin and neoruscogenin compounds. Due to these properties, R. aculeatus stands out as a traditional phytotherapy agent that has been used for a long time in chronic venous insufficiency. However, there are no controlled clinical studies in the literature evaluating the efficacy and safety of Ruscus aculeatus L. in hemorrhoidal disease. Therefore, this study was aimed to systematically evaluate the contribution of a phytotherapeutic product containing R. aculeatus to the treatment of stage II-III hemorrhoidal patients and to provide scientific evidence of a new and potentially safe herbal treatment option that can be used in the treatment of hemorrhoids.
Detailed description
The aim of this study was to evaluate the efficacy and safety of Neoven 225 mg capsule containing Ruscus aculeatus L. in individuals with stage II-III hemorrhoidal disease according to the Goligher classification.
Hemorrhoidal disease is characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. As a result, venous distension, inflammation, erosion, bleeding and thrombosis may develop in hemorrhoidal tissues.
Clinically, depending on the stage of the disease, symptoms such as bright red rectal bleeding during defecation, discomfort around the anus, itching, fecal incontinence, pain and protrusion may occur. However, uncertainty about the pharmacological treatment of hemorrhoidal disease still remains.
Unlike advanced stage (stage IV) hemorrhoids, which require surgical intervention, various topical agents (gels, ointments, creams), oral venoactive drugs, homeopathic and phytotherapeutic products and nutritional supplements are widely used in stage II and III hemorrhoidal disease. Among oral venoactive drugs, synthetic calcium dobesilate, diosmin-hesperidin combination of natural origin, triterpenes and saponins are the most well-known compounds. The genus Ruscus (family Asparagaceae) is a group of plants native to the Mediterranean basin, Southern and Western Europe, and Iran, represented by perennial, rhizome-based, and evergreen shrubs. Among the species belonging to this genus, Ruscus aculeatus L. has the widest distribution area. The subsoil parts of the Ruscus plant are rich in steroidal saponins and show vasoconstrictor, diuretic, anti-inflammatory and venotonic effects, especially with ruscogenin and neoruscogenin compounds. Due to these properties, R. aculeatus stands out as a traditional phytotherapy agent that has been used for a long time in chronic venous insufficiency.
However, there are no controlled clinical studies in the literature evaluating the efficacy and safety of Ruscus aculeatus L. in hemorrhoidal disease. Therefore, this study was aimed to systematically evaluate the contribution of a phytotherapeutic product containing R. aculeatus to the treatment of stage II-III hemorrhoidal patients and to provide scientific evidence of a new and potentially safe herbal treatment option that can be used in the treatment of hemorrhoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: Neoven 225 mg capsules | Active comparator | Drug: Neoven 225 mg capsulesPatients in this group will only use Neoven 225 mg capsules orally. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. A total of 378 mg of total ruscogenin (ruscogenin/neoruscogenin mixture obtained by extraction method) will be taken orally using one Neoven capsule orally with meals twice a day. A total of 84 capsules will be given to the patients. |
| Control group | Placebo comparator | Drug: PlaceboPatients in this group will only receive an oral placebo capsule designed for this study. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. During this period, one placebo capsule will be taken orally twice a day with meals. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18-45 with complaints (symptomatic) consistent with hemorrhoidal disease
- Patients with Stage II and III hemorrhoids according to the Goligher Hemorrhoid Rating system using physical examination (digital rectal examination, anoscopy/rectoscopy performed within a maximum of four weeks before the examination)
- Patients who have signed the Informed Consent Form
Key exclusion criteria (7 listed)
- Patients aged <18 and >45 years
- Stage I and IV hemorrhoids according to the Goligher Hemorrhoid Rating system
- Surgery for hemorrhoids at any time
- Injection treatment for multiple hemorrhoids in the last 3 years
- Perianal sepsis, inflammatory bowel disease, colorectal malignancy, or pre-existing sphincter injury within the last 3 years
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 |
|---|---|---|
| Neoven 225 mg capsulesPatients in this group will only use Neoven 225 mg capsules orally. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. A total of 378 mg of total ruscogenin (ruscogenin/neoruscogenin mixture obtained by extraction method) will be taken orally using one Neoven capsule orally with meals twice a day. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study. | Drug | Study group: Neoven 225 mg capsules |
| PlaceboPatients in this group will only receive an oral placebo capsule designed for this study. There will be no signs or inscriptions on the capsules regarding their contents. The duration of the study is determined as 42 days. During this period, one placebo capsule will be taken orally twice a day with meals. A total of 84 capsules will be given to the patients, and their use will be questioned by phone on the 7th and 14th days of the treatment and the number of uses will be checked at the end of the treatment. Failure to use all of the capsules will be considered as a criterion for exclusion from the study. | Drug | Control group |
Primary outcome
Quality of Life for HSS (Hemorrhoid Severity Score)
Time frame: At the end of the treatment (42nd day)
Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of pruritis, pain, prolapse, bleeding and soiling. All the five components in this classification system are graded into four grades ranging from 0 to 3.
2 secondary outcomes
Hemorrhoidal Disease Symptom Score (HHSS)
Time frame: At the end of the treatment (42nd day)
Visual Analog Scale (VAS)
Time frame: At the end of the treatment (42nd day)
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 19 Aug 2025.
- Background: PubMed 7692161Bouskela E, Cyrino FZ, Marcelon G. Effects of Ruscus extract on the internal diameter of arterioles and venules of the hamster cheek pouch microcirculation. J Cardiovasc Pharmacol. 1993 Aug;22(2):221-4. doi: 10.1097/00005344-199308000-00008.
- Background: PubMed 27825178Masullo M, Pizza C, Piacente S. Ruscus Genus: A Rich Source of Bioactive Steroidal Saponins. Planta Med. 2016 Dec;82(18):1513-1524. doi: 10.1055/s-0042-119728. Epub 2016 Nov 8.
- Background: PubMed 14612852Boyle P, Diehm C, Robertson C. Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. Int Angiol. 2003 Sep;22(3):250-62.
- Background: PubMed 33983078Pompilio G, Nicolaides A, Kakkos SK, Integlia D. Systematic literature review and network Meta-analysis of sulodexide and other drugs in chronic venous disease. Phlebology. 2021 Oct;36(9):695-709. doi: 10.1177/02683555211015020. Epub 2021 May 13.
- 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.
Haluk Kerim KARAKULLUKCU, MD principal investigator
Sultan Abdulhamid Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neoven 225 mg capsules in people with Hemorrhoid, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 19 Aug 2025. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Haluk Kerim Karakullukcu, MD (+905384357181, halukkarakkulukcu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life for HSS (Hemorrhoid Severity Score) (time frame: At the end of the treatment (42nd day)). 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 NCT07128979, which also lists 4 linked publications.
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 19 Aug 2025.