Skip to content

Comparative study on observational efficacy of Naoxin'an capsule in the treatment of stroke

Comparative study on observational efficacy of Naoxin'an capsule in the treatment of stroke

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110680
Enrollment
Unknown
Registered
2025-10-17
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Cerebrovascular disease

Interventions

Case series:none

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for acute ischemic stroke; 2.Meet the diagnosis of any one of the syndrome elements of qi deficiency, blood stasis, phlegm dampness, and internal fire; 3.Patients admitted within 7 days of onset; 4.Age >= 18 years old; 5.Taking Naoxin'an capsule; 6.The patient or his legal representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. People who are known to be allergic to Naoxin'an capsules or related pharmaceutical ingredients; 2.Those who have a previous history of stroke and have residual sequelae that affect the outcome evaluation, i.e., the mRS score before the onset of this stroke is >= 2 points; 3.Patients with severe liver and renal insufficiency (Note: Severe liver insufficiency is defined as ALT or AST greater than 3 times the upper limit of normal; severe renal insufficiency is defined as blood creatinine greater than 2 times the upper limit of normal; 4.Patients with other life-threatening serious diseases with an expected survival time of less than 3 months; 5.Pregnant, planned, or lactating women; 6.Other diseases that significantly limit the evaluation of neurological function or affect patient follow-up; 7.Patients or their caregivers cannot cooperate in completing follow-up work.

Design outcomes

Primary

MeasureTime frame
Improvement of neurological deficits (changes in NIHSS score);Changes in Consciousness (changes in GCS score) ;Disability Status (Change in mRS and BI Scores)?;Incidence of acute cardiovascular and cerebrovascular events;Incidence of cognitive impairment and changes in MoCA scores;Angina Pectoris in Patients with Coronary Heart Disease;

Secondary

MeasureTime frame
Complications;All cause and attributable mortality: proportion of patients who died;Changes in the diagnostic scale of syndrome elements of ischemic stroke;Total expenses and treatment expenses during hospitalization;Post-discharge medication costs and rehabilitation costs;Cost effectiveness ratio;

Countries

China

Contacts

Public ContactKong Lingbo

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

klb1984@163.com+86 131 6732 3987

Outcome results

None listed

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