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治験 NCT07501962（対象：大腸内視鏡検査）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate 440
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07501962 は 介入研究 臨床試験 で、大腸内視鏡検査 に関するものです。現在は 募集準備中 で、2026年4月1日 に開始予定です。440 名の参加者 の募集が計画されています。この試験は The First Affiliated Hospital of Zhengzhou University によって主導され、2026年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月30日 です。
概要
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol rel...もっと見る
公式タイトル
Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study
疾患名
大腸内視鏡検査その他の研究識別子
- 2026-KY-0394-001
主目的
診断
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Menthol group Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. | Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. |
プラセボ対照薬placebo group Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. | Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of intestinal spasm | Intestinal spasm score:
Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter.
Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter.
Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized.
The maximum diameter is defined as the diameter of the intestinal lumen when fully distended.
Spasm incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group. | Day 0 |
adenoma detection rate (ADR) | ADR = (Number of patients with at least one adenomatous polyp detected / Total number of patients in the group) × 100%.
Pathological diagnosis was used as the gold standard. | Day 0 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Spasm inhibition rate | The percentage of patients whose lumen opening exceeded two-thirds of the maximum diameter within 30 seconds after water injection irrigation, relative to the total number of patients in the group. | Day 0 |
Polyp detection rate (PDR) | PDR = (Number of patients with at least one polyp detected / Total number of patients in the group) × 100%. | Day 0 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age between 18 and 75 years, regardless of gender;
- Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
- Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
- Voluntarily signed informed consent and able to cooperate with completing study-related assessments.
- Allergy to menthol, cyclodextrin, or related substances;
- History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
- Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
- Pregnant or lactating women;
- Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
- Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
- History of contraindications to colonoscopy or serious adverse reactions during previous procedures.
The First Affiliated Hospital of Zhengzhou University責任者
Jianning Yao, 主任研究者, Chief Physician, The First Affiliated Hospital of Zhengzhou University
試験中央連絡先
連絡先: Jianning Yao, 13733183434, [email protected]
位置情報がありません。