Efficacy and safety of xinxuening capsule in the treatment of patients with ischemic stroke and hyperhomocysteinemia: a randomized, double-blind, controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018371

Enrollment

Unknown

Registered

2018-09-13

Start date

2018-10-10

Completion date

Unknown

Last updated

2018-09-17

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

Conditions

Patients with ischemic stroke and hyperhomocysteinemia

Interventions

Experimental:Xinxuening capsule and Folic Acid Placebo

Positive Comparator:Xinxuening Placebo Capsul and Folic Acide

Placebo Comparator:Xinxuening Placebo Capsul and Folic Acid Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female or male aged = 18 years; 2. Ischemic stroke; 3. Within 30 days from symptom onset; 4. Hyperhomocysteinemia(total serum homocysteine >15 µmol/L); 5. Provision of informed consent.

Exclusion criteria

Exclusion criteria: 1. Head CT or MRI findings of hemorrhage or other pathological brain diseases, such as vascular malformations, tumors, abscesses, encephalitis or other common non-ischemic brain diseases (such as multiple sclerosis); 2. accompanied by autoimmune diseases; 3. vitamin B12 deficiency causes megaloblastic anemia; 4. Gastric tumors or complications, severe liver disease (ALT 3 times higher than the upper limit of normal), kidney disease (eGFR < 90 ml/min/1.73 m2), other malignant tumors and alcoholism, etc.; Note: According to the modified MDRD formula suitable for Chinese, the estimated glomerular filtration rate (eGFR): eGFR (ml/min/1.73m2) = 175 * creatinine - 1.234 * age - 0.179 * 0.79 (female). 5. Special treatment history (radiotherapy, chemotherapy, hormones, immunosuppressive agents, and biological agents) 1 month before randomization; 6. Use of folic acid or folic acid-containing drugs (such as leaves), Pueraria lobata, hawthorn or methotrexate) that affect HCY within one month before randomization; Note: The drugs affecting HCY include Xinxuening Capsule, Xinxuening Tablet, Pueraria Injection, Hawthorn Pill, Tangchen Beijianye Pueraria Extract Tablet, Yixinshu Capsule, Xinkeshu Tablet, Songling Xuemaikang Capsule, Enalapril Maleate Folic Acid Tablet and Methotrexate. 7. suffering from severe non cardio cerebrovascular diseases, the expected survival time is less than 3 months; 8. women of childbearing age who have negative pregnancy tests but refuse to take effective contraception measures; 9. is undergoing experimental drug or instrument tests; 10. participated in other clinical drug research in the past 30 days; 11. inability to understand and / or follow up research procedures and / or follow up for mental illness, cognitive or emotional disorders; 12. other researchers believe that patients who are not suitable for the study.

Design outcomes

Primary

Measure	Time frame
Elevated homocysteinemia;Adverse event;Death;	—

Secondary

Measure	Time frame
Curative effect between different genotypes;Changes of biomarker;Neurological recovery;Combined vascular events;Modified Rankin Scale;Serious adverse events;	—

Countries

China

Contacts

Public ContactYongjun Wang

Beijing Tiantan Hospital

yongjunwang@ncrcnd.org.cn+86 010 67098350

Outcome results

None listed

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