Ruscus Genus: A Rich Source of Bioactive Steroidal Saponins.
Milena Masullo, Cosimo Pizza, Sonia Piacente
https://pubmed.ncbi.nlm.nih.gov/27825178/Actively Recruiting
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
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
Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids
H
Haluk Kerim Karakullukcu, MD
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead Sponsor
Atabay Kimya Sanayi Ticaret A.S.
Collaborating Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Milena Masullo, Cosimo Pizza, Sonia Piacente
https://pubmed.ncbi.nlm.nih.gov/27825178/Giuseppe Pompilio, Andrew Nicolaides, Stavros K Kakkos...
https://pubmed.ncbi.nlm.nih.gov/33983078/E Bouskela, F Z Cyrino, G Marcelon
https://pubmed.ncbi.nlm.nih.gov/7692161/P Boyle, C Diehm, C Robertson
https://pubmed.ncbi.nlm.nih.gov/14612852/Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead Sponsor
Atabay Kimya Sanayi Ticaret A.S.
Collaborating Sponsor