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

Ischemic Stroke Clinical Trial

— TREASURE  

Official title:

Efficacy and Safety of Mongolian Medicine ZhenBao Pills on Limb Function Recovery After Acute Ischemic Stroke: a Randomized Double-blinded Placebo-controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049498
• Other study ID #: HX-DZM-202227
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Dongzhimen Hospital, Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores	Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.	90 days after randomization
Secondary	Modified Rankin scale (mRS) scores	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.)	90 days after randomization
Secondary	FMA-UE scores	Difference in FMA-UE scores between baseline and 30 days after randomization.	30 days after randomization
Secondary	The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores	Difference in FMA-LE scores (range =0-34, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.	90 days after randomization
Secondary	National Institutes of Health Stroke Scale (NIHSS) scores	Difference in NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 90 days after randomization.	90 days after randomization
Secondary	The Barthel index of activity of daily living (BI)	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).	90 days after randomization
Secondary	Visual analogue scale (VAS) scores	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).	90 days after randomization