N/A N=300 Randomized Quadruple-blind Treatment

War-Drill Model Guided Treatment of Hemorrhoids With Nimsai Herbal (NAJ)

Hemorrhoids · Hemorrhoidal Disease

Bottom Line

View on ClinicalTrials.gov: NCT07034820 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Hemorrhoid Regression Rate — 117; 33 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nimsai Herbal (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nimsai Academia
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemorrhoid Regression Rate	117; 33	<0.001 sig

Summary

This study investigated a new understanding of hemorrhoid formation and evaluated a novel systemic treatment. For 200 years, hemorrhoids were conventionally understood as isolated swollen veins. However, our new "War-Drill Model" proposes that hemorrhoids are primarily caused by blood pooling (venous congestion) in the anal region, which then secondarily leads to vascular deformation. This congestion is hypothesized to arise from either underlying health issues ("War Mode") or natural physiological and hormonal changes ("Drill Mode"). We conducted a double-blind, placebo-controlled randomized controlled trial on 300 patients with Grade 2-3 hemorrhoids to evaluate the efficacy and safety of Nimsai Herbal. This study explores the potential for "War Mode" hemorrhoids to serve as an early warning sign for other serious underlying conditions and aims to validate a novel systemic therapeutic approach.

Eligibility Criteria

Inclusion Criteria

Endoscopically confirmed Grade 2 or 3 internal hemorrhoids.

History of hemorrhoidal symptoms >6 weeks.

Age 18-70 years at the time of enrollment.

Provided written informed consent prior to any study-related procedures.

Willingness and ability to comply with all study procedures and follow-up visits.

Exclusion Criteria

Grade 1 or 4 hemorrhoids.

Any known anorectal malignancy or suspicion of malignancy.

Pregnancy or lactation.

Known hypersensitivity or allergy to Nimsai Herbal components or placebo ingredients.

Significant systemic diseases (e.g., severe cardiovascular, renal, hepatic, or hematological disorders) that could affect study participation or safety.

Participation in another clinical trial within 30 days prior to screening.

Any condition that, in the opinion of the investigator, might compromise the safety of the participant or the integrity of the study data.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07034820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.