Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial (NAJ2)
Quadruple-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a prospective, single-center, quadruple-blind, placebo-controlled, parallel-group randomized controlled trial designed as a mechanistic signal-detection study. The trial evaluates the War-Drill Model of hemorrhoid pathogenesis, which proposes that venous congestion, rather than primary vascular deformation, constitutes the indispensable initiating event in hemorrhoid formation. The model distinguishes two hemodynamic phenotypes: War Mode, associated with systemic inflammation and sustained venous congestion, and Drill Mode, characterized by hormonally mediated transient venous engorgement.
A total of 50 participants with endoscopically confirmed Grade 2-3 internal hemorrhoids and symptom duration exceeding 6 weeks will be randomized 1:1 to Nimsai Herbal (600 mg once daily) or matching placebo for 10 consecutive days. The study employs quadruple blinding, with participants, care providers, investigators, and outcomes assessors all masked to treatment assignment. An independent Data Safety Monitoring Board will provide ongoing safety oversight.
The primary outcome is hemorrhoid regression rate at Day 10, defined as either reduction in Goligher grade or ≥75% reduction in composite severity score. Secondary outcomes include mean change in self-reported symptom severity (VAS) and complete symptom resolution rate. Safety outcomes include incidence of mild gastrointestinal discomfort, serious adverse events, and withdrawals due to adverse events. Diabetic participants will be specifically monitored for transient diarrhea during Days 1-3.
The Parola Phenomenon, a patient-reported clinical indicator, will be assessed at baseline to stratify participants into War Mode and Drill Mode phenotypes for exploratory subgroup analyses.
The trial is prospectively registered on ClinicalTrials.gov and approved by the Nimsai Academia Ethics Committee. Written informed consent will be obtained from all participants. The complete study protocol, statistical analysis plan, and de-identified individual participant data will be made publicly available through the Dryad Digital Repository.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Cem Atabiner
- Número de telefone: 05324593292
- E-mail: info@nimsai.com
Locais de estudo
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Bursa, Turquia (Türkiye)
- Nimsai Academia Clinical Research Center
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Contato:
- Cem Atabiner
- Número de telefone: 05324593292
- E-mail: info@nimsai.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Nimsai Herbal Group
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).
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600 mg oral capsule taken once daily.
Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.
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Comparador de Placebo: Placebo Group
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.
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Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hemorrhoid Regression Rate
Prazo: Day 10
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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).
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Day 10
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual Analog Scale Symptom Score Change
Prazo: Baseline to Day 10
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Mean change from baseline in self-reported overall hemorrhoid symptom severity at Day 10, measured on a 0-10 Visual Analog Scale (0 = no symptoms, 10 = most severe symptoms).
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Baseline to Day 10
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Symptom Resolution Rate
Prazo: Day 10
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Percentage of participants achieving complete resolution of all baseline hemorrhoid symptoms (composite severity score = 0) at Day 10.
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Day 10
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Mild Gastrointestinal Discomfort
Prazo: Baseline to Day 10
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Percentage of participants reporting mild gastrointestinal adverse events (nausea, bloating, dyspepsia) during the 10-day intervention period.
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Baseline to Day 10
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Incidence of Serious Adverse Events
Prazo: Baseline to Day 10
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Percentage of participants experiencing serious adverse events as defined by ICH GCP guidelines during the 10-day intervention period.
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Baseline to Day 10
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Incidence of Transient Diarrhea in Diabetic Participants
Prazo: Days 1-3
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Number of diabetic participants experiencing transient diarrhea resolving spontaneously within 24-48 hours during the first three days of the intervention.
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Days 1-3
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Atabiner C. The War-Drill Model of Hemorrhoid Pathogenesis. Research Square. 2025. doi:10.21203/rs.3.rs-6607959/v1
Links úteis
Datas de registro do estudo
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- NA-2026-01
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- PROTOCOLO DE ESTUDO
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- CIF
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