Coronary Heart DiseasePhase 1/2NCT07493603
A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease
A Phase 1/2 study testing Yiyang Huoluo Decoction and conventional western medicine treatment in people with Coronary Heart Disease and Coronary Artery Disease, run by Xia Liang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Coronary Artery Disease, Atheroscleroses
- What is being tested?
- Yiyang Huoluo Decoction and conventional western medicine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Anji
Huzhou, Zhejiang
Xiaoli Lu
About this study
Official title: Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
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:
Read more
- 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.
- Being tested
- Yiyang Huoluo Decoction, conventional western medicine treatment
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiyang Huoluo DecoctionDrug
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)
conventional western medicine treatmentDrug
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
| Study group | Role | What they receive |
|---|---|---|
| YH group | Experimental | receive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents Receives: Drug: Yiyang Huoluo Decoction; Drug: conventional western medicine treatment |
| Control Group | Other | only receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents Receives: Drug: conventional western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: baseline, 12 weeks, and 36 weeks of treatment
CCS angina pectoris grade
Measured: baseline, 12 weeks, 36 weeks of treatment
Incidence of in-stent restenosis
detected by coronary angiography
Measured: 36-week of treatment
Secondary outcomes (2)
Changes in carotid intima-media thickness (IMT)
detected by carotid ultrasound
Measured: baseline, 12 weeks, and 36 weeks of treatment
Total incidence of adverse events (AEs)
Measured: during the 36-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start16 Jan 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xia Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xia Liang, Hangzhou City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493603
- Sponsor's protocol ID
- 20250050
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
- ClinicalTrials.gov ID
- NCT07493603
- Acronym / sponsor ID
- 20250050
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xia LiangUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YH group | Experimental | Drug: Yiyang Huoluo Decoction, Drug: conventional western medicine treatmentreceive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
| Control Group | Other | Drug: conventional western medicine treatmentonly receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yiyang Huoluo DecoctionThe 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) | Drug | YH group |
| conventional western medicine treatmentincluding antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents | Drug | Control Group, YH group |
Primary outcome
TCM syndrome scores for chest discomfort due to yang qi deficiency and decline
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.)
CCS angina pectoris grade
Time frame: baseline, 12 weeks, 36 weeks of treatment
Incidence of in-stent restenosis
Time frame: 36-week of treatment
detected by coronary angiography
2 secondary outcomes
Changes in carotid intima-media thickness (IMT)
Time frame: baseline, 12 weeks, and 36 weeks of treatment
Total incidence of adverse events (AEs)
Time frame: during the 36-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Yiyang Huoluo Decoction and conventional western medicine treatment in people with Coronary Heart Disease and Coronary Artery Disease, run by Xia Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Xia, Doctor (86-15057172609, 407928215@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM syndrome scores for chest discomfort due to yang qi deficiency and decline (time frame: baseline, 12 weeks, and 36 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.