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

Double-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids

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.

The current understanding of hemorrhoid pathogenesis has remained largely unchanged for over two centuries, positing hemorrhoids primarily as isolated venous dilatations or prolapses. This traditional view, however, fails to adequately explain the high recurrence rates post-treatment, the limited efficacy of topical agents, and the often-debilitating symptomatology. Our extensive research, culminating in the "War-Drill Model" and the "Sine Qua Non Hypothesis," fundamentally challenges this conventional paradigm. We propose that hemorrhoids are not primarily structural abnormalities but rather a manifestation of underlying venous congestion, which then secondarily leads to vascular deformation and associated symptoms. This congestion acts as the indispensable (sine qua non) prerequisite for the development of both symptomatic and asymptomatic hemorrhoidal disease.

The "War-Drill Model" further categorizes this venous congestion based on its etiology:

War Mode Hemorrhoids: These are hypothesized to arise from chronic or passive venous congestion triggered by an underlying systemic or local inflammatory process or pathology. Examples include inflammatory bowel diseases (Crohn's disease, ulcerative colitis), anal fissures, rectal polyps, liver diseases causing portal hypertension, and various other systemic conditions affecting vascular flow or integrity. Crucially, "War Mode" hemorrhoids may serve as a critical "biological early-warning system," prompting investigations that could lead to the early diagnosis of up to 20 distinct and potentially severe internal diseases.

Drill Mode Hemorrhoids: These are hypothesized to be transient vascular engorgements resulting from physiological hormonal fluctuations, typically observed during periods of significant endocrine change such as adolescence, pregnancy, lactation, menopause, and andropause. These episodes are often self-limiting, resolving as hormonal balance stabilizes.

To validate a systemic therapeutic approach based on this new model, we conducted a double-blind, placebo-controlled, parallel-group Randomized Controlled Trial (RCT) (Protocol ID: NA-2024-01). The study enrolled 300 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids and a history of symptoms for over 6 weeks. Participants were randomized to receive either Nimsai Herbal (a novel systemic botanical formulation, 600 mg daily) or an identical placebo for 10 consecutive days.

The primary outcome measure was hemorrhoid regression rate, defined as a reduction of at least one Goligher grade by Day 10, assessed via anoscopic examination and clinical evaluation. Secondary outcomes included incidence of adverse events. The study utilized the "Parola Phenomenon," a simple clinical maneuver designed by Atabiner, as part of patient assessment, aiming to differentiate War Mode from Drill Mode hemorrhoids.

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.