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

NCT07034820 | Completed Results DMC

• 1 other identifier: NA-2024-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhoids; Hemorrhoidal Disease

Keywords

Hemorrhoids; Hemorrhoidal Disease; Pathogenesis; War-Drill Model; Sine Qua Non Hypothesis; Venous Congestion; Nimsai Herbal; Randomized Controlled Trial; Clinical Trial; Treatment; Early Diagnosis; Biological Early-Warning System; Inflammatory Bowel Disease; Anal Fissure; Rectal Polyps; Hormonal Fluctuations; Parola Phenomenon; Systemic Therapy; Gastroenterology

Outcome Measures

Primary Outcomes (1)

• Hemorrhoid Regression Rate

  Hemorrhoid regression was defined as a reduction of at least one Goligher grade or a ≥75% reduction in composite hemorrhoid severity score by Day 10. (The Goligher Classification of Hemorrhoids is a 4-point scale (Grade I to IV) used for hemorrhoid severity, where higher scores indicate worse disease.)

  Day 10 (end of treatment period)

Study Arms (2)

Nimsai Herbal Group

EXPERIMENTAL

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

Dietary Supplement: Nimsai Herbal

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Nimsai Herbal 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.

Nimsai Herbal Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nimsai Academia: lead

Study Sites (1)

Nimsai Academia Clinical Research Center

Bursa, Turkey (Türkiye)

Location

Related Links

• Official website of Nimsai Academia, providing general information about the research institution and its activities.

MeSH Terms

Conditions

Hemorrhoids; Hyperemia; Disease; Inflammatory Bowel Diseases; Fissure in Ano

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Anus Diseases

Limitations and Caveats

This RCT focused on Grade 2-3 hemorrhoids; efficacy in Grade 1 and 4 needs further study. The short 14-day follow-up necessitates longer-term cohort studies for sustained effects. The Parola Phenomenon, though accurate, requires objective validation beyond clinical assessment. No formal blinding evaluation was conducted. Future research should explore potential genetic and microbiota interactions.

Results Point of Contact

• Title: Cem Atabiner, Principal Investigator
• Organization: Nimsai Academia

cem.atabiner@kecioutdoor.com.tr

05324593292

Study Officials

• Cem Atabiner

  Nimsai Academia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: October 10, 2021
• Primary Completion: October 20, 2021
• Study Completion: November 14, 2021
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data and supporting information will be available starting 6 months after the official publication of the primary manuscript in a peer-reviewed journal. The data will remain accessible indefinitely thereafter, or for as long as ethically and legally permissible under relevant data privacy regulations and institutional policies.
• Access Criteria: Access to de-identified individual participant data (IPD) and supporting documentation (including the study protocol, statistical analysis plan, and informed consent form) will be granted to qualified researchers. Researchers must submit a methodologically sound and ethically approved research proposal that aligns with the original study's objectives or adds significant scientific value. Access will be provided through a secure, controlled-access platform, requiring a signed Data Use Agreement (DUA) between the requesting institution and Nimsai Academia. This agreement will outline strict terms for data use, confidentiality, and proper attribution, ensuring compliance with all applicable privacy regulations (e.g., GDPR, HIPAA equivalents). Data will be used solely for non-commercial scientific research purposes.

Locations

TU (1)