Actively Recruiting

Phase 4
Age: 18Years - 45Years
All Genders
NCT07128979

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

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sultan Abdulhamid Training and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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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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