Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Hemorrhoid, Hemorrhoidal Disease
In brief
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.
Key facts
- Study ID
- NCT07669662
- Run by
- Nimsai Academia
- People needed
- 50
- Starts
- 2026-06-22
- Expected to finish
- 2026-07-02
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nimsai Academia Clinical Research Center — Bursa, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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