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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2021-11-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhoids Hemorrhoidal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomized to either the Nimsai Herbal group or the placebo group, with both groups receiving treatment concurrently.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study employed a robust double-blind design where the Nimsai Herbal and placebo treatments were identical in appearance, taste, and packaging. In addition to participants, care providers, investigators, and outcomes assessors, the independent data monitoring committee and third-party statisticians involved in the primary data analysis were also masked to treatment assignments. The unblinding codes were securely held by a designated unmasked statistician who was not involved in the interim analyses or daily study conduct.

Study Groups

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Nimsai Herbal Group

Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.

Group Type EXPERIMENTAL

Nimsai Herbal

Intervention Type DIETARY_SUPPLEMENT

Oral Nimsai Herbal is a novel botanical formulation, administered as one 600 mg capsule per day for a duration of 10 consecutive days. It is specifically designed to target the underlying venous congestion hypothesized by the War-Drill Model, aiming to promote hemorrhoid regression and symptom resolution.

Placebo Group

Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

This intervention consisted of an oral placebo, formulated to be identical in appearance, taste, and packaging to Nimsai Herbal. It was administered as one capsule per day for 10 consecutive days to ensure blinding and serve as a control for comparison.

Interventions

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Nimsai Herbal

Oral Nimsai Herbal is a novel botanical formulation, administered as one 600 mg capsule per day for a duration of 10 consecutive days. It is specifically designed to target the underlying venous congestion hypothesized by the War-Drill Model, aiming to promote hemorrhoid regression and symptom resolution.

Intervention Type DIETARY_SUPPLEMENT

Placebo

This intervention consisted of an oral placebo, formulated to be identical in appearance, taste, and packaging to Nimsai Herbal. It was administered as one capsule per day for 10 consecutive days to ensure blinding and serve as a control for comparison.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cem Atabiner

Role: PRINCIPAL_INVESTIGATOR

Nimsai Academia

Locations

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Nimsai Academia Clinical Research Center

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol: In Vitro Mechanistic Evidence (Figures S2 and S3)

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Document Type: Study Protocol: Study Protocol ( Protocol NA-2024-01 )

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Study Documents

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Document Type: Study Protocol

Access is subject to ethical approval of the research proposal by the Nimsai Academia Ethics Committee and the execution of a Data Use Agreement. Researchers must agree to use the data solely for scientific research and to respect participant privacy.

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