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To explore the multi-center clinical and mechanism study of Tongnayin promoting angiogenesis after ischemic stroke based on MEK/ERK/AP-1 pathway

To explore the multi-center clinical and mechanism study of Tongnayin promoting angiogenesis after ischemic stroke based on MEK/ERK/AP-1 pathway

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078956
Enrollment
Unknown
Registered
2023-12-21
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Ischemic stroke

Interventions

The treatment group:Basic treatment + rehabilitation treatment + Tongnaoyin
The control group:Basic treatment + rehabilitation treatment

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Between 40 and 75 years old, both sexes; (2) The onset time was less than 7 days and brain MRI examination was performed within 24 hours after treatment; (3) meeting the Western diagnostic criteria for acute ischemic stroke, with cerebral infarction lesions confirmed by brain CT or MRI; (4) Large atherosclerotic stroke in accordance with TOAST classification; (5) Infarction consistent with unilateral middle cerebral artery and/or internal carotid artery stenosis or occlusion; (6) The NIHSS score ranged from 5 to 15; (7) In line with the diagnostic criteria of stroke in traditional Chinese medicine, the syndrome differentiation was phlegm and blood stasis syndrome; (8) Volunteer, sign written informed consent, have good compliance, adhere to follow-up, and go to the hospital by themselves. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) There are definite contraindications for the use of antiplatelet aggregation drugs. (2) Allergic constitution, such as allergic history to two or more drugs or food, allergic to proprietary Chinese medicine containing leech or suspected allergic to leech ingredients in the past; (3) Patients with severe gastrointestinal diseases such as gastric and duodenal ulcer and perforation history, which affect the absorption of drugs; (4) have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as cancer or AIDS; (5) Patients with a history of mental illness or disability; (6) According to the judgment of the investigator, other lesions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment, etc., are likely to cause loss of follow-up; (7) Patients who are taking part in clinical observation of other drugs.

Design outcomes

Primary

MeasureTime frame
National Institute of Health stroke scale;

Secondary

MeasureTime frame
Computed tomography angiography and perfusion;

Countries

China

Contacts

Public ContactMinghua Wu

Jiangsu Province Hospital of Chinese Medicine

mhuawu@163.com+86 139 5178 6719

Outcome results

None listed

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