Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial (NCT07669662) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial
Turkey (Türkiye)50 participantsStarted 2026-06-22
Plain-language summary
This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Endoscopically confirmed Grade 2 or 3 internal hemorrhoids
History of hemorrhoidal symptoms persisting for more than 6 weeks prior to screening
Age 18 to 70 years inclusive at time of informed consent
Willingness and ability to provide written informed consent
Willingness and ability to comply with all study procedures, schedules, and follow-up requirements
Exclusion Criteria:
* Diagnosis of Grade 1 or Grade 4 hemorrhoids
Any known anorectal malignancy or suspicion of malignancy
Active bleeding from sources other than hemorrhoids
Currently pregnant or lactating women, or women of childbearing potential not using effective contraception
Known hypersensitivity or allergy to any component of Nimsai Herbal or placebo
Significant systemic diseases including severe cardiovascular disease, severe renal impairment, severe hepatic dysfunction, or uncontrolled diabetes mellitus (HbA1c \> 9%)
Any medical or psychiatric condition that might compromise participant safety or data integrity
Participation in another interventional clinical trial within 30 days prior to screening
Use of concurrent treatments for hemorrhoids within 7 days prior to screening
History of hemorrhoidectomy or other invasive hemorrhoid procedures within the last 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.