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Efficacy and Safety Evaluation of Shenling Baigui Granules in Patients with Ischemic Stroke Combined with Stable Angina Pectoris: An Assessment of Superiority and Safety

Study on the Optimization and Efficacy Evaluation of the Shenling Baigui Granules a Cardiovascular and Cerebrovascular Formula from Renowned Traditional Chinese Medicine Practitioners Based on "Objective Performance Criteria - Mendelian Randomization"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000814
Enrollment
Unknown
Registered
2024-12-13
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Ischemic Stroke and Stable Angina Pectoris

Interventions

Study Population:Oral Administration of Shenling Baigui Granules

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: **Inclusion Criteria:** 1. Meets the diagnostic criteria for ischemic stroke (IS) based on medical history and CT/MRI examination and is consistent with the TOAST classification for large artery atherosclerosis and small artery occlusion infarction. 2. Meets the diagnostic criteria for stable angina pectoris (SAP) based on medical history clinical symptoms and imaging examinations (electrocardiogram echocardiography coronary CT angiography or coronary angiography). 3. Diagnosis according to traditional Chinese medicine (TCM) includes syndromes of "Stroke" and "Chest Pain" with stroke classified as being in the recovery phase (onset of 7 to 14 days excluding 7 days and including 14 days). 4. Age between 60 and 75 years. 5. Clinical neurological deficit severity for IS as assessed by the NIHSS score ranges from 4 to 20 (inclusive); mRS score at inclusion is =2. 6. Classified as New York Heart Association (NYHA) functional class I or II. 7. Informed consent is signed by the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: **Exclusion Criteria:** 1. Cranial imaging confirms diseases causing similar symptoms such as brain tumors encephalitis or brain abscess; transient ischemic attack (TIA) hemorrhagic stroke or mixed-type stroke. 2. Ischemic stroke caused by other reasons or of unknown origin epidural hematoma intraventricular hemorrhage or subarachnoid hemorrhage. 3. Patients with implanted cardiac pacemakers or those with comorbid conditions such as heart failure or acute coronary syndrome (ACS). 4. Presence of acute or chronic infections. 5. Inability to cooperate with clinical data collection. 6. Severe liver or kidney dysfunction (ALT or AST levels greater than twice the upper limit of normal or creatinine levels above the upper limit of normal) or severe pulmonary diseases. 7. Pregnant or breastfeeding women or those with plans to conceive in the near future. 8. Known allergy to or intolerance of the core prescription components. 9. Swallowing disorders preventing oral administration of medication. 10. Patients with mental disorders. 11. Participation in other clinical trials currently or within the past month. 12. Any other condition deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale (mRS) Score;Canadian Cardiovascular Society (CCS) Angina Classification;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS) Score;High-Sensitivity C-Reactive Protein (hs-CRP);Homocysteine (Hcy);New York Heart Association (NYHA) Classification;Angina Attack Duration;Seattle Angina Questionnaire (SAQ);Traditional Chinese Medicine Syndrome Indicators;

Countries

China

Contacts

Public ContactJingjing Wei

Xiyuan Hospital of China Academy of Chinese Medical Sciences

dr.jianlyu-tcm@outlook.com18701583785

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026