Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke (NCT06049498) | Clinical Trial Compass
CompletedNot Applicable
Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
China216 participantsStarted 2024-01-01
Plain-language summary
The trial was designed to test the hypothesis that treatment with Mongolian Medicine ZhenBao Pills has a positive effect on upper-limb motor recovery after acute ischemic stroke.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult subjects (male or female ≥18 years).
. The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
. Patients with prestroke modified Rankin scale score 0-1.
. FAM-UE score of 20-57 at randomization.
. The patients and legal guardians signed informed consent.
Exclusion criteria
. Cranial CT or MRI findings of hemorrhage or other pathologic brain disorders, such as vascular malformations, tumors, abscesses, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis).
. 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).
. Coagulation disorders or history of systemic hemorrhage.
. Life expectancy is less than 3 months.
. Unable to complete the study due to mental illness, cognitive or emotional impairment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
. Suspected or known allergy to the components of the trial medication.
. Pregnancy, breastfeeding or potential pregnancy.
. Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.