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

NCT07034820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-07-31

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

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.

Sponsors & Collaborators

  • Nimsai Academia

    lead OTHER

Principal Investigators

  • Cem Atabiner · Nimsai Academia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2021-10-20
Completion
2021-11-14

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034820 on ClinicalTrials.gov