A New Approach to Identify Characteristics of Similar Chinese Patent Medicine for Post- Stroke Based on Comparative Effectiveness Research

Comparative effectiveness evaluation method for personalization of Chinese patent medicines in clinical effect based on Patient Important Outcome

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-OPN-16008374

Enrollment

Unknown

Registered

2016-05-07

Start date

2016-05-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

STROKE

Interventions

1:Naoxuekang capsule

2:Xinnaoshutong Capsule

3:xuesetongCapsule

4:Routine medication

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 30 to 65 years old; 2. The stroke should be the first incidence; 3. Diagnosis of unilateral, non-recurring, subacute stroke of ischemic and lacunar type, as defined by the International Classification of Diseases (ICD-10) through computed omography or magnetic resonance imaging conducted by neurologists; 4. TCM pattern diagnosis of stroke in meridian syndrome; 5. Patients should have a National Institutes of Health Stroke Scale (NIHSS) score between 6and12; 6. After injury from four weeks to eight weeks; 7. Provision of signed informed consent; 8. The above inclusion criteria will be applied to the experimental group and the control group.

Exclusion criteria

Exclusion criteria: 1. Patients have a history of stroke; 2. Known history of allergy or suspected allergy to the study drug. 3. Patients suffered from serious heart, liver or kidney-related diseases, blood coagulation dysfunction or severe mental disorders; 4. Uncontrolled NYHA class III hypertension (systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg); 5. Fasting blood glucose 16.8 mmol/l or with severe complications due to diabetes (e.g., peripheral neuropathy, or diabetic gangrene); 6. Liver function impairment with the value of alanine aminotransferase (ALT) or aspartate aminotransaminase (AST) over 1.5-fold the upper limit of normal range; 7. Renal dysfunction with the value of serum creatinine over 1.5-fold the upper limit of normal range; 8. Participation in another clinical trial, either currently or within the past 3 months; 9. Presence of active peptic ulcers and other hemorrhagic diseases; 10. Patients with other complications who should not be included in the trial as adjudged by the recruiting personnel.

Design outcomes

Primary

Measure	Time frame
NIHSS;	—

Countries

China

Contacts

Public ContactHongbo Cao

Tianjin University of Traditional Chinese Medicine

caohongboebm@foxmail.com+86 13752330880

Outcome results

None listed

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