Actively Recruiting
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-08-19
250
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
S
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead Sponsor
A
Atabay Kimya Sanayi Ticaret A.S.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 45 with symptoms of hemorrhoidal disease
- Stage II or III hemorrhoids confirmed by physical exam and anoscopy or rectoscopy within 4 weeks
- Signed informed consent form
You will not qualify if you...
- Patients younger than 18 or older than 45 years
- Stage I or IV hemorrhoids
- Previous hemorrhoid surgery
- Injection treatment for multiple hemorrhoids in the past 3 years
- Perianal sepsis, inflammatory bowel disease, colorectal cancer, or sphincter injury in the last 3 years
- Immunodeficiency
- Presence of anal fissures or perianal fistulas
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sultan Abdulhamid Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
H
Haluk Kerim Karakullukcu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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