Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke (TREASURE)

Dongzhimen Hospital, Beijing

Status: Not yet enrolling

Conditions: Ischemic Stroke

Treatments: Drug: Mongolian Medicine ZhenBao Pills; Drug: Mongolian Medicine ZhenBao Pills Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06049498

HX-DZM-202227

Details and patient eligibility

About

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.

Full description

The study is a randomized, double-blinded, placebo-controlled, multi-center trial.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult subjects (male or female ≥18 years).
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

1. 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).
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 2 patient groups, including a placebo group

Mongolian Medicine ZhenBao Pills group

Experimental group

Description:

Experimental group

Treatment:

Drug: Mongolian Medicine ZhenBao Pills

Mongolian Medicine ZhenBao Pills Placebo-controlled group

Placebo Comparator group

Description:

Placebo-controlled group

Treatment:

Drug: Mongolian Medicine ZhenBao Pills Placebo