Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial

NCT07669662 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NA-2026-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.

Conditions

Hemorrhoid; Hemorrhoidal Disease

Keywords

venous stasis; War-Drill Model; Parola Phenomenon; phytotherapy; Nimsai Herbal; quadruple-blind

Outcome Measures

Primary Outcomes (1)

• Hemorrhoid Regression Rate

  Percentage of participants achieving a clinical response at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score from baseline. The composite score is the sum of clinician-assessed scores for pain, bleeding, itching, and swelling, each rated on a 0-10 Visual Analog Scale (total range 0-40).

  Day 10

Secondary Outcomes (2)

• Visual Analog Scale Symptom Score Change

  Baseline to Day 10

• Symptom Resolution Rate

  Day 10

Other Outcomes (3)

• Incidence of Mild Gastrointestinal Discomfort

  Baseline to Day 10

• Incidence of Serious Adverse Events

  Baseline to Day 10

• Incidence of Transient Diarrhea in Diabetic Participants

  Days 1-3

Study Arms (2)

Nimsai Herbal Group

EXPERIMENTAL

Participants in this arm will receive Nimsai Herbal capsules (600 mg) orally once daily for 10 consecutive days. Nimsai Herbal is a proprietary oral phytotherapeutic formulation. The product is approved as a food supplement by the Turkish Ministry of Agriculture and Forestry (TEG Approval No: 015473-13.12.2022).

Dietary Supplement: Nimsai Herbal

Placebo Group

PLACEBO COMPARATOR

Participants in this arm will receive placebo capsules identical in appearance, taste, and packaging to Nimsai Herbal, administered orally once daily for 10 consecutive days.

Other: Placebo

Interventions

Nimsai Herbal DIETARY_SUPPLEMENT

600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.

Nimsai Herbal Group

Placebo OTHER

Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.

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 persisting for more than 6 weeks prior to screening
• Age 18 to 70 years inclusive at time of informed consent
• Willingness and ability to provide written informed consent
• Willingness and ability to comply with all study procedures, schedules, and follow-up requirements

You may not qualify if:

• Diagnosis of Grade 1 or Grade 4 hemorrhoids
• Any known anorectal malignancy or suspicion of malignancy
• Active bleeding from sources other than hemorrhoids
• Currently pregnant or lactating women, or women of childbearing potential not using effective contraception
• Known hypersensitivity or allergy to any component of Nimsai Herbal or placebo
• Significant systemic diseases including severe cardiovascular disease, severe renal impairment, severe hepatic dysfunction, or uncontrolled diabetes mellitus (HbA1c \> 9%)
• Any medical or psychiatric condition that might compromise participant safety or data integrity
• Participation in another interventional clinical trial within 30 days prior to screening
• Use of concurrent treatments for hemorrhoids within 7 days prior to screening
• History of hemorrhoidectomy or other invasive hemorrhoid procedures within the last 6 months

Sponsors & Collaborators

• Nimsai Academia: lead

Study Sites (1)

Nimsai Academia Clinical Research Center

Bursa, Turkey (Türkiye)

Location

Related Publications (1)

• Atabiner C. The War-Drill Model of Hemorrhoid Pathogenesis. Research Square. 2025. doi:10.21203/rs.3.rs-6607959/v1

  BACKGROUND

Related Links

• Nimsai Academia Research Information

MeSH Terms

Conditions

Hemorrhoids; Varicose Ulcer

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Cem Atabiner

CONTACT

05324593292; info@nimsai.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to the four masked parties listed above, the independent data monitoring committee and third-party statisticians conducting the primary data analysis were also masked to treatment assignments. Unblinding codes were securely held by a designated unmasked statistician not involved in interim analyses or daily study conduct.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 25, 2026
• Study Start: June 22, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 2, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication of the primary manuscript in a peer-reviewed journal. Data will remain accessible indefinitely thereafter, or for as long as ethically and legally permissible under relevant data privacy regulations.
• Access Criteria: Qualified researchers who submit a methodologically sound and ethically approved research proposal. Access requires a signed Data Use Agreement between the requesting institution and Nimsai Academia. Data will be shared through a secure controlled-access platform and used solely for non-commercial scientific research purposes.

Locations

TU (1)