Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Hemorrhoid
In brief
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.
Key facts
- Study ID
- NCT07128979
- Run by
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- People needed
- 250
- Starts
- 2025-08-01
- Expected to finish
- 2026-11-02
- Last updated by the study team
- 2025-08-19
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sultan Abdulhamid Training and Research Hospital — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.