People's Hospital of Anji
Huzhou, Zhejiang, China
Location status: Recruiting
Location contact
Xiaoli Lu
CONTACT
NCT Number: NCT07493603
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 medical care improve symptoms and heart-related health in older adults with coronary heart disease and atherosclerosis? * Is Yiyang Huoluo Decoction safe for older adults to take alongside their regular heart medications? * How does this herbal treatment affect the damaged blood vessels in study participants?
Researchers will compare two groups of participants to see if the combined treatment works better than standard care alone.
Who can take part: Older adults diagnosed with coronary heart disease and atherosclerosis who meet the study's health and eligibility rules.
What participants will do:
* Be split randomly into two groups of 15 people each: one group gets standard Western heart medicine only, and the other gets standard Western heart medicine plus Yiyang Huoluo Decoction (herbal granules) * Complete the 12-week decoction treatment plan as directed by the research team * Attend scheduled study visits for health checks, blood tests, heart and blood vessel scans (such as carotid ultrasound and coronary CTA), and symptom reviews * Provide two small blood samples for research testing (samples will be destroyed after study testing is finished) * Report any side effects, discomfort, or changes in health to the research team right away
All personal health information collected for this study will be kept private and confidential. Participation is completely voluntary, and participants may quit the study at any time for any reason without losing access to regular medical care.
Interested in participating?
Request Info50 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Huzhou, Zhejiang, China
Location status: Recruiting
Xiaoli Lu
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All of the following conditions must be met simultaneously for enrollment:
Exclusion criteria
Participants will be excluded if they meet any of the following conditions:
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 (earthworm), Persicae Semen (peach seed), and Carthami Flos (safflower)
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
Time frame: baseline, 12 weeks, and 36 weeks of treatment
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.)
Time frame: baseline, 12 weeks, 36 weeks of treatment
Time frame: 36-week of treatment
detected by coronary angiography
Time frame: baseline, 12 weeks, and 36 weeks of treatment
detected by carotid ultrasound
Time frame: during the 36-week treatment period
Contact information is provided by the study sponsor or research team.
Xia Liang
Other
Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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