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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Cem Atabiner
- 電話番号：05324593292
- メール：info@nimsai.com
研究場所
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Bursa、トルコ（Türkiye）
- Nimsai Academia Clinical Research Center
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コンタクト：
- Cem Atabiner
- 電話番号：05324593292
- メール：info@nimsai.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemorrhoid Regression Rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Visual Analog Scale Symptom Score Change
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Mild Gastrointestinal Discomfort
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Atabiner C. The War-Drill Model of Hemorrhoid Pathogenesis. Research Square. 2025. doi:10.21203/rs.3.rs-6607959/v1
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NA-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
試験データ・資料
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。