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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke
• Interventions: Drug: Mongolian Medicine ZhenBao Pills; Drug: Mongolian Medicine ZhenBao Pills Placebo

• Registration Number: NCT06049498
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-07-24
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Study Start: 2023-10-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mongolian Medicine ZhenBao Pills group	Mongolian Medicine ZhenBao Pills	Experimental group
Mongolian Medicine ZhenBao Pills Placebo-controlled group	Mongolian Medicine ZhenBao Pills Placebo	Placebo-controlled group

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores	90 days after randomization	Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.

Secondary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS) scores	90 days after randomization	Difference in the distribution of patient mRS scores (mRS scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.)
FMA-UE scores	30 days after randomization	Difference in FMA-UE scores between baseline and 30 days after randomization.
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores	90 days after randomization	Difference in FMA-LE scores (range =0-34, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.
National Institutes of Health Stroke Scale (NIHSS) scores	90 days after randomization	Difference in NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 90 days after randomization.
The Barthel index of activity of daily living (BI)	90 days after randomization	Difference in BI scores between baseline and 90 days after randomization. Functional independence will be measured with BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
Visual analogue scale (VAS) scores	90 days after randomization	Difference in VAS scores between baseline and 90 days after randomization. The patients' pain level measured with VAS, which was a conventionally used scale measuring the degree of the pain. Score of scale ranges from 0（best）to 10 (worst).

Trial Locations

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China