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Prospective multi-center single-arm clinical study of Qingre Huatan Decoction in the treatment of acute ischemic stroke with large atherosclerosis

Prospective multi-center single-arm clinical study of Qingre Huatan Decoction in the treatment of acute ischemic stroke with large atherosclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000413
Enrollment
Unknown
Registered
2024-09-11
Start date
2024-09-16
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Ischemic stroke

Interventions

intervention group:Qingrehuatan formula

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) meet the diagnosis of acute ischemic stroke; (2) Meeting the diagnosis of large atherosclerotic stroke; (3) Onset within 72 hours; (4) 18 years = age =80 years; (5) 4 points =NIHSS score =25 points; (6) consistent with the diagnosis of phlegm-heat syndrome; (7) The patient or legal representative gives informed consent and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who have received or intend to receive intravenous thrombolysis or endovascular interventional therapy (including endovascular mechanical thrombolysis arterial thrombolysis and angioplasty); (2) Stroke patients who have been confirmed by examination to be caused by brain tumors brain trauma blood diseases infectious diseases genetic diseases and rheumatological and immune diseases; (3) Patients with a history of stroke and residual sequelae affecting the outcome assessment that is mRS Score =2 points before the onset of stroke; (4) Patients with claudication osteoarthritis rheumatoid arthritis gouty arthritis etc. which lead to limb mobility dysfunction and affect neurological function examination; (5) Patients with severe liver and renal insufficiency (liver insufficiency means ALT or AST greater than 2 times the upper limit of normal renal insufficiency means Cr greater than 2 times the upper limit of normal); (6) suffering from other life-threatening serious diseases with an expected survival time of less than 3 months; (7) Combined with other diseases that limit the evaluation of neurological function or affect patient follow-up; (8) Women who are pregnant planning pregnancy or breastfeeding; (9) Currently participating in other interventional clinical investigators.

Design outcomes

Primary

MeasureTime frame
Proportion of excellent functional outcome (mRS 0-1);

Secondary

MeasureTime frame
Evaluation of syndromes of phlegm dampness and internal fire;Distribution of mRS;Diagnosis of TCM syndrome elements of ischemic stroke;Life quality evaluation;Any new vascular event (ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction);Any new stroke event (ischemic or hemorrhagic);Degree of neurological impairment;activities of daily living;Proportion of good functional outcomes (mRS 0-2);

Countries

China

Contacts

Public ContactYing Gao

Dongzhimen Hospital Beijing University of Chinese Medicine

gaoying973@126.com13366275973

Outcome results

None listed

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