Trial Radar IA | ||
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Lo studio clinico NCT07493603 per Malattia cardiaca coronarica, Malattia dell'arteria coronaria, Atheroscleroses è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease Fase I, Fase II 30
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07493603 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per Malattia cardiaca coronarica, Malattia dell'arteria coronaria, Atheroscleroses, attualmente in arruolamento. Avviato il 16 gennaio 2026, prevede di arruolare 30 partecipanti. Sotto la guida di Xia Liang, dovrebbe concludersi entro il 30 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
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...
Titolo ufficiale
Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
Patologie
Malattia cardiaca coronaricaMalattia dell'arteria coronariaAtherosclerosesAltri ID dello studio
- 20250050
Numero NCT
Data di inizio (effettiva)
2026-01-16
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2028-06-30
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Fase II
Stato
In arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleYH 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 (...Mostra di più conventional western medicine treatment including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
AltroControl 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 |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
50 Years
Sessi idonei
Tutti
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 LiangParte responsabile dello studio
Xia Liang, Promotore-investigatore, professor, Hangzhou City University
Contatti principali dello studio
Contatto: Liang Xia, Doctor, 86-15057172609, [email protected]
1 Centri dello studio in 1 paesi
Zhejiang
People's Hospital of Anji, Huzhou, Zhejiang, China
Xiaoli Lu, Contatto
In arruolamento