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Randomized controlled study of Huanglian Jiedu Decoction in treating acute ischemic apoplexy syndrome

Multi-omics linkage study of Huanglian Jiedu Decoction and its effective components regulating "central-peripheral" immune interaction in the treatment of acute ischemic stroke based on the fiery theory of Hejian School

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001076
Enrollment
Unknown
Registered
2025-05-29
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

acute ischemic stroke

Interventions

Experimental group:On the basis of conventional treatment and standard nursing rehabilitation in western medicine, the oral administration of Huanglian Jiedu Decoction was added (the drugs were Huangl
contrast group:Alongside conventional Western medicine therapy and standard rehabilitative care patients received an oral placebo mimicking Huanglian Jiedu Granules administered in parallel (twice dai

Sponsors

Cangzhou Hospital of Integrated Chinese and Western Medicine Hebei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for acute ischemic stroke; (2) It meets the diagnostic criteria of ischemic stroke middle meridian acute phase and internal fire syndrome of TCM; (3) Hospital admission within 72 hours of onset; (4) Patients with a National Institutes of Health Stroke Scale (NIHSS) score of 6 =NIHSS=20 at the time of presentation; (5) Age less than 75 years old; (6) The patient or his legal representative is able and willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: (1)Coma patients; (2) Those who plan or have already undergone thrombolytic or intravascular therapy; (3) secondary stroke due to blood diseases intracranial space occupation brain trauma and other reasons; (4) Allergic constitution allergic to the test drug or related ingredients; (5) Patients whose blood pressure is still 220/120mmHg after basic treatment with Western medicine; (6) Severe hepatic and renal insufficiency (defined as serum creatinine concentration alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 2 times the upper limit of normal); (7) Those who have a tendency to bleed or have experienced severe bleeding within 3 months; (8) serious primary diseases of the cardiovascular system liver kidney or blood system immune deficiency diseases tumors mental disorders cognitive disorders; (9) Motor dysfunction caused by other diseases (such as severe osteoarthropathy rheumatoid arthritis immune system diseases etc.); (10) Patients with autoimmune diseases those who are currently or recently using immune agents for treatment and those who have other diseases affecting immune function; (11) A life expectancy of no more than 3 months due to other life-threatening diseases (such as advanced cancer); (12) Those who are participating in other clinical trials or participating in other drug clinical trials less than 3 months after completion; (13) Pregnant and lactating women;

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS) ;

Secondary

MeasureTime frame
Neurologic function and quality of survival scores;Imaging test;Biomarkers (blood routine, urine routine, biochemistry, peripheral blood lymphocyte subsets, inflammatory factors);TCM apoplexy symptom and syndrome score;Incidence of cardiovascular events;mortality rate;

Countries

China

Contacts

Public ContactQingguo Wang

Beijing University of Chinese Medicine

542775038@qq.com13601183429

Outcome results

None listed

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