Nimsai Herbal: 600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.
Placebo: Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Hemorrhoid Regression Rate — Day 10 Percentage of participants achieving a clinical response at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score from baseline. The composite score is the sum of clinician-assessed scores for pain, bleeding, itching, and swelling, each rated on a 0-10 Visual Analog Scale (total range 0-40).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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