NCT07128979

Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids

Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids: A Randomized, Double-blind Phase IV Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Hemorrhoid

Interventions

Type	Name	Description
DRUG	Neoven 225 mg capsules	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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-11-02
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: Turkey (Türkiye)