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Die klinische Studie NCT07493603 für Koronare Herzkrankheit, Koronararterienerkrankung, Atheroscleroses ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease Phase 1, Phase 2 30

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07493603 untersucht Behandlung im Zusammenhang mit Koronare Herzkrankheit, Koronararterienerkrankung, Atheroscleroses. Diese interventionsstudie der Phase 1 Phase 2 hat den Status offene rekrutierung und startete am 16. Januar 2026. Es ist geplant, 30 Teilnehmer aufzunehmen. Durchgeführt von Xia Liang wird der Abschluss für 30. Juni 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. März 2026 aktualisiert.
Kurzbeschreibung

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...
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Offizieller Titel

Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction

Erkrankungen
Koronare HerzkrankheitKoronararterienerkrankungAtheroscleroses
Weitere Studien-IDs
  • 20250050
NCT-Nummer
NCT07493603
Studienbeginn (tatsächlich)
2026-01-16
Zuletzt aktualisiert
2026-03-25
Studienende (vorauss.)
2028-06-30
Geplante Rekrutierung
30
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellYH 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 (...Mehr anzeigen
conventional western medicine treatment
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
AndereControl 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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
50 Years
Zugelassene Geschlechter
Alle

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 logoXia Liang
Verantwortliche Partei
Xia Liang, Prüfsponsor, professor, Hangzhou City University
Zentrale Studienkontakte
Kontakt: Liang Xia, Doctor, 86-15057172609, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

People's Hospital of Anji, Huzhou, Zhejiang, China
Xiaoli Lu, Kontakt
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