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

ConditionHemorrhoid
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Neoven 225 mg capsules
  • Placebo

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators