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

Sponsor

Dongzhimen Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06049498

Collaborator

(none)

216

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Mongolian Medicine ZhenBao Pills Drug: Mongolian Medicine ZhenBao Pills Placebo	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mongolian Medicine ZhenBao Pills group Experimental group	Drug: Mongolian Medicine ZhenBao Pills Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Placebo Comparator: Mongolian Medicine ZhenBao Pills Placebo-controlled group Placebo-controlled group	Drug: Mongolian Medicine ZhenBao Pills Placebo Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.

Arm

Intervention/Treatment

Experimental: Mongolian Medicine ZhenBao Pills group

Experimental group

Drug: Mongolian Medicine ZhenBao Pills

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

Placebo Comparator: Mongolian Medicine ZhenBao Pills Placebo-controlled group

Placebo-controlled group

Drug: Mongolian Medicine ZhenBao Pills Placebo

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

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.
Within three months or currently participating in another investigational study.
Other patients who, in the opinion of the investigator, are not suitable for participation of the study.