Neoven (Ruscus aculeatus 225 mg) capsules for adults with stage II–III hemorrhoids

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

This test will see if Neoven (Ruscus aculeatus 225 mg) capsules reduce symptoms in adults aged 18–45 with stage II–III hemorrhoids.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Academic / other)
• Locations: 1 site (Istanbul)
• Trial ID: NCT07128979 on ClinicalTrials.gov

What this trial studies

Adults aged 18–45 with symptomatic stage II–III hemorrhoids are enrolled and receive either Neoven 225 mg capsules containing Ruscus aculeatus L. or a matching placebo. The trial tracks symptom changes and safety using clinical examination (including anoscopy/rectoscopy performed within four weeks of baseline) and patient-reported outcomes. Key exclusions include prior hemorrhoid surgery, recent injection treatments, perianal sepsis, inflammatory bowel disease, colorectal malignancy, and other anorectal pathology. The study is conducted at Sultan Abdulhamid Training and Research Hospital in Istanbul with industry collaboration.

Who should consider this trial

Good fit: Adults 18–45 with symptomatic stage II–III hemorrhoids by Goligher classification who can undergo required exams and who have not had prior hemorrhoid surgery are the intended participants.

Not a fit: Patients with stage I or IV hemorrhoids, prior hemorrhoid surgery, recent injection therapy, perianal sepsis, inflammatory bowel disease, colorectal malignancy, or those outside the 18–45 age range are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If effective, Neoven could reduce bleeding, pain, and prolapse symptoms and provide a non-surgical treatment option for stage II–III hemorrhoids.

How similar studies have performed: Some small trials of venoactive and phytotherapeutic products, including Ruscus-containing preparations or diosmin combinations, have reported symptomatic benefits, but overall evidence is limited and mixed.

Eligibility criteria

Inclusion Criteria:

1. Patients between the ages of 18-45 with complaints (symptomatic) consistent with hemorrhoidal disease
2. 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)
3. Patients who have signed the Informed Consent Form

Exclusion Criteria:

* 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 this trial is running

Istanbul

• Sultan Abdulhamid Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Haluk Kerim KARAKULLUKCU, MD — Sultan Abdulhamid Training and Research Hospital
• Study coordinator: Haluk Kerim Karakullukcu, MD

Conditions Hemorrhoid