Homocysteine, inflammatory factors, safety study of scutellarin for injection in patients with acute cerebral infarction - a single center, randomized, open label clinical trial

Phase 4

• Conditions: Acute cerebral infarction

• Registration Number: ITMCTR2100005042
• Lead Sponsor: Yunnan Third People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for acute ischemic stroke;
2. Patients with mild to moderate elevation of homocysteine;
3. The time from onset of stroke symptoms or signs to treatment is <=72 hours;
4. The modified Rankin Scale (mRS) score of the first onset or before onset is between 0 and 1;
5.4<=NIHSS score<=15 points;
6. Age 18-80 years old (including 18 and 80 years old), gender is not limited;
7. Voluntarily participate and sign the informed consent.

Exclusion Criteria

1. Due to encephalitis, brain tumor, brain abscess and diseases that cause similar symptoms;
2. Transient ischemic attack;
3. Patients who are using traditional Chinese medicine injections for promoting blood circulation and removing blood stasis (including Danshen preparations, Ginkgo preparations, and Xuesaitong preparations);
4. Patients who are using folic acid, vitamin B6 or vitamin B12;
5. Have bleeding disorders or bleeding tendency;
6. Patients treated with vascular opening (such as thrombolysis, arterial thrombectomy, ultra-early thrombus aspiration and stenting, etc.) after the onset;
7. Patients with severe disturbance of consciousness (NIHSS 1a consciousness level item >= 2 points);
8) Those with other diseases that affect the function of limb movement, such as claudication, osteoarthritis (active stage), rheumatoid arthritis (active stage), gouty arthritis, etc. The limb movement dysfunction may affect the nerve or functional examination By;
9. Combined with severe cardiovascular disease (New York Heart Function Class (NYHA) grade III and above, unstable angina pectoris, myocardial infarction within 6 months before administration, uncontrolled arrhythmia, etc.);
10. Severe liver and kidney dysfunction;
11. Patients with tumors and other serious diseases of the system;
12. Those who are known to be allergic to the components of the test drug and have allergic constitution;
13. Women who are pregnant, planning to become pregnant or breastfeeding;
Patients who participated in other clinical trials within 14.3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Homocysteine level;