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

NCT ID: NCT06049498

Last Updated: 2023-09-22

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mongolian Medicine ZhenBao Pills group

Experimental group

Group Type EXPERIMENTAL

Mongolian Medicine ZhenBao Pills

Intervention Type DRUG

Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.

Mongolian Medicine ZhenBao Pills Placebo-controlled group

Placebo-controlled group

Group Type PLACEBO_COMPARATOR

Mongolian Medicine ZhenBao Pills Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Mongolian Medicine ZhenBao Pills Placebo

Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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HX-DZM-202227

Identifier Type: -

Identifier Source: org_study_id

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