Effects of Ruscus extract on the internal diameter of arterioles and venules of the hamster cheek pouch microcirculation.
E Bouskela, F Z Cyrino, G Marcelon
https://pubmed.ncbi.nlm.nih.gov/7692161Actively Recruiting
Phase 4
Age: 18Years - 45Years
All Genders
ID07128979
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids: A Randomized, Double-blind Phase IV Clinical Trial
Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-08-19
250
Participants Needed
1
Research Sites
13 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
Researchers are studying the effects of Ruscus aculeatus L., a plant known for its vasoconstrictor, diuretic, anti-inflammatory, and venotonic properties, on patients with stage II-III hemorrhoidal disease. Hemorrhoidal disease involves deterioration of vascular cushions in the anal canal, causing symptoms like bleeding, discomfort, and pain. This research aims to provide scientific evidence on a new herbal treatment option for hemorrhoids. The study compares the use of Neoven 225 mg capsules containing Ruscus aculeatus L. with a placebo. Participants will take one capsule twice daily with meals for 42 days, receiving a total of 84 capsules. The active capsules contain a mixture of ruscogenin and neoruscogenin compounds. Capsule use will be monitored by phone calls on days 7 and 14, and pill counts at the end of treatment. Participants will be evaluated for quality of life using the Hemorrhoid Severity Score at the end of 42 days. Additional assessments include the Hemorrhoidal Disease Symptom Score and a Visual Analog Scale for symptoms. Researchers will monitor adherence to treatment and the safety of the herbal product throughout the study period, which is led by Sultan Abdulhamid Han Training and Research Hospital.
CONDITIONS
Brief Title
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
Who Can Participate
Age: 18Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 45 years
- Patients with symptomatic stage II or III hemorrhoids confirmed by physical examination within the last 4 weeks
- Patients who have signed the informed consent form
You will not qualify if you...
- Patients younger than 18 or older than 45 years
- Patients with stage I or IV hemorrhoids
- Patients who have had hemorrhoid surgery at any time
- Patients who received injection treatment for multiple hemorrhoids in the last 3 years
- Patients with perianal sepsis, inflammatory bowel disease, colorectal cancer, or sphincter injury within the last 3 years
- Patients with anal fissures or perianal fistulas detected during examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 42 days
Participants take Neoven 225 mg capsules or placebo capsules orally twice a day with meals to evaluate the efficacy and safety of the treatment for hemorrhoidal disease.
Phone calls on Day 7 and Day 14; 1 final in-person visit at the end of treatment
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
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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