A Phase 4 interventional study of Neoven 225 mg capsules and Placebo in Hemorrhoid, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Phase 4, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Neoven 225 mg capsules
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.
Drug: Placebo
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.
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.
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.
Time frame: At the end of the treatment (42nd day)
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.
Time frame: 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
Time frame: At the end of the treatment (42nd day)
Plan to share: No
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