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A multicenter, randomized, open-label clinical trial on the modification of Fuyuan Xingnao Decoction for the treatment of ischemic stroke with coronary artery disease.

A multicenter, randomized, open-label clinical trial on the modification of Fuyuan Xingnao Decoction for the treatment of ischemic stroke with coronary artery disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001497
Enrollment
Unknown
Registered
2026-06-17
Start date
2026-06-25
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke combined with coronary artery disease

Interventions

Experimental Group 1:In addition to conventional Western medical treatment, Fuyuan Xingnao Tang is also administered.
Experimental Group 2:In addition to routine Western medical treatment, Fuyuan Xingnao Decoction and Zhujie Shen are administered.

Sponsors

Yichang Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: The following criteria must be met to participate in the study: 1. Meets the diagnostic criteria for coronary heart disease combined with ischemic stroke. 2. Age between 30–85 years old, regardless of gender. 3. Have not used any traditional Chinese medicine formulations in the past two weeks. 4. Voluntarily participates in clinical observation, signs the informed consent form, and is willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Any of the following criteria disqualify inclusion in clinical observation: 1. Patients with valvular heart disease, various types of cardiomyopathy, malignant arrhythmias, or NYHA class III-IV heart failure. 2. Individuals with acute coronary syndrome/acute myocardial infarction within the past 6 months, or planned to undergo PCI/CABG within 4-8 weeks. 3. Poorly controlled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg) with short-term instability. 4. Patients with severe pulmonary insufficiency (PaO2 7.0%), severe primary hematologic diseases, abnormal liver function (transaminase levels exceeding 2x upper normal limit), abnormal kidney function (serum creatinine Cr: >106 umol/L in males, >97 umol/L in females), or acute cerebrovascular events within the past 3 months. 5. Organ transplant recipients, individuals with allergy history to Chinese or Western medicine, or inability to tolerate Chinese medicine. 6. Pregnant, breastfeeding, or planning pregnancy in the near term. 7. Participants in other drug/device clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale;

Secondary

MeasureTime frame
TCM Syndrome Score;Seattle Angina Questionnaire;Weekly angina episodes;Angina Pectoris Symptom Scoring Scale;Nitroglycerin Usage and Cessation Rate;National Institutes of Health Stroke Scale;Blood lipids;Serum inflammatory Factors;

Countries

China

Contacts

Public ContactAnfeng Xiang

Yichang Hospital of Traditional Chinese Medicine

afxiang0101@163.com+86 159 7166 7172

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026