Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
NCT ID: NCT06049498
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
216 participants
INTERVENTIONAL
2023-10-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mongolian Medicine ZhenBao Pills group
Experimental group
Mongolian Medicine ZhenBao Pills
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Mongolian Medicine ZhenBao Pills Placebo-controlled group
Placebo-controlled group
Mongolian Medicine ZhenBao Pills Placebo
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
Interventions
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Mongolian Medicine ZhenBao Pills
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Mongolian Medicine ZhenBao Pills Placebo
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
Eligibility Criteria
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Inclusion Criteria
2. The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
3. Patients with prestroke modified Rankin scale score 0-1.
4. FAM-UE score of 20-57 at randomization.
5. The patients and legal guardians signed informed consent.
Exclusion Criteria
2. Chronic liver disease or elevated ALT, AST (greater than two times the upper limit of normal), renal insufficiency or elevated blood creatinine (greater than 1.5 times the upper limit of normal).
3. Coagulation disorders or history of systemic hemorrhage.
4. Life expectancy is less than 3 months.
5. Unable to complete the study due to mental illness, cognitive or emotional impairment.
6. Suspected or known allergy to the components of the trial medication.
7. Pregnancy, breastfeeding or potential pregnancy.
8. Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.
9. Within three months or currently participating in another investigational study.
10. Other patients who, in the opinion of the investigator, are not suitable for participation of the study.
18 Years
ALL
No
Sponsors
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Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Ying Gao
Professor
Principal Investigators
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Ying Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital
Locations
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Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, , China
Countries
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Other Identifiers
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HX-DZM-202227
Identifier Type: -
Identifier Source: org_study_id
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