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治験 NCT07493603（対象：冠動脈性心疾患、冠動脈疾患、Atheroscleroses）は募集中です。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
A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease 第I相・フェーズ1, 第II相・フェーズ2 30
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 NCT07493603 は 冠動脈性心疾患、冠動脈疾患、Atheroscleroses に関する 治療 の研究で、第I相・フェーズ1 第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2026年1月16日 から開始しています。30 名の参加者 の募集が計画されています。この試験は Xia Liang によって主導され、2028年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月25日 です。
概要
The goal of this clinical trial is to learn if Yiyang Huoluo Decoction (a custom Chinese herbal medicine) works safely and effectively to treat coronary heart disease with atherosclerosis in older adults. It also aims to find out how this herbal treatment may affect blood vessel health and repair at a cellular level.
The main questions it aims to answer are:
- Does adding Yiyang Huoluo Decoction to standard Western...
公式タイトル
Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
疾患名
冠動脈性心疾患冠動脈疾患Atherosclerosesその他の研究識別子
- 20250050
NCT番号
開始日
2026-01-16
最終更新日
2026-03-25
終了予定日
2028-06-30
目標参加者数
30
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
第II相・フェーズ2
第II相・フェーズ2
状況
募集中
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的YH group receive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents | Yiyang Huoluo Decoction The principal constituents of this decoction include Rehmanniae Radix (dried rehmannia root), Dioscoreae Rhizoma (Chinese yam rhizome), Cornus Officinalis Fructus (Asiatic dogwood fruit), Alismatis Rhizoma (water plantain rhizome), Poria Cocos (Indian bread), Moutan Cortex (moutan bark), Cinnamomi Ramulus (cinnamon twig), Astragali Radix (milk vetch root), Angelicae Sinensis Radix (Chinese angelica root), Pheretima (...もっと見る conventional western medicine treatment including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
その他Control Group only receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents | conventional western medicine treatment including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
TCM syndrome scores for chest discomfort due to yang qi deficiency and decline | TCM Syndrome Rating Scale for Chest Discomfort (Yang Qi Deficiency and Decline) (It includes 8 main symptoms, each scored 0-3, with a total score of 0-24. Higher scores represent more severe syndromes.) | baseline, 12 weeks, and 36 weeks of treatment |
CCS angina pectoris grade | baseline, 12 weeks, 36 weeks of treatment | |
Incidence of in-stent restenosis | detected by coronary angiography | 36-week of treatment |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes in carotid intima-media thickness (IMT) | detected by carotid ultrasound | baseline, 12 weeks, and 36 weeks of treatment |
Total incidence of adverse events (AEs) | during the 36-week treatment period |
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
50 Years
対象性別
全て
All of the following conditions must be met simultaneously for enrollment:
- ① Meet the diagnostic criteria for stable angina pectoris;
- ② Classified as Grade I to III according to the Canadian Cardiovascular Society (CCS) Angina Grading Scale;
- ③ Meet the diagnostic criteria for chest discomfort syndrome due to yang qi deficiency and decline (a traditional Chinese medicine pattern differentiation);
- ④ Aged between 50 and 75 years old;
- ⑤ Received drug-eluting stent implantation due to severe vascular stenosis (single artery ≥75%， or LM ≥50%) detected by coronary angiography;
- ⑥ Able to actively comply with medical instructions and voluntarily sign the written informed consent form.
Participants will be excluded if they meet any of the following conditions:
- ① Diagnosed with acute coronary syndrome (including acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, and unstable angina pectoris) after relevant examinations;
- ② Suffer from chest pain caused by non-cardiac diseases other than stable angina pectoris; or have complicated severe hypertension (systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg), severe cardiopulmonary insufficiency, or malignant tumor;
- ③ Have severe endocrine, hematological or rheumatic immune system diseases, severe hepatic and renal dysfunction, active gastrointestinal bleeding, or mental illness;
- ④ Have an allergic constitution or a history of allergic reactions to traditional Chinese medicine;
- ⑤ Have incomplete major baseline data that may affect the trial results, or have participated in other clinical trials recently.
Xia Liang責任者
Xia Liang, 治験依頼者・主任研究者, professor, Hangzhou City University
試験中央連絡先
連絡先: Liang Xia, Doctor, 86-15057172609, [email protected]
1 1カ国の場所
Zhejiang
People's Hospital of Anji, Huzhou, Zhejiang, China
Xiaoli Lu, 連絡先
募集中