search
Back to results

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

Primary Purpose

Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mongolian Medicine ZhenBao Pills
Mongolian Medicine ZhenBao Pills Placebo
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dongzhimen Hospital, Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mongolian Medicine ZhenBao Pills group

Mongolian Medicine ZhenBao Pills Placebo-controlled group

Arm Description

Experimental group

Placebo-controlled group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.)
FMA-UE scores
Difference in FMA-UE scores between baseline and 30 days after randomization.
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.
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.
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).
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).

Full Information

First Posted
July 24, 2023
Last Updated
September 15, 2023
Sponsor
Dongzhimen Hospital, Beijing
search

1. Study Identification

Unique Protocol Identification Number
NCT06049498
Brief Title
Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
The study is a randomized, double-blinded, placebo-controlled, multi-center trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mongolian Medicine ZhenBao Pills group
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Mongolian Medicine ZhenBao Pills Placebo-controlled group
Arm Type
Placebo Comparator
Arm Description
Placebo-controlled group
Intervention Type
Drug
Intervention Name(s)
Mongolian Medicine ZhenBao Pills
Intervention Description
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Intervention Type
Drug
Intervention Name(s)
Mongolian Medicine ZhenBao Pills Placebo
Intervention Description
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
Primary Outcome Measure Information:
Title
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
Description
Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.
Time Frame
90 days after randomization
Secondary Outcome Measure Information:
Title
Modified Rankin scale (mRS) scores
Description
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.)
Time Frame
90 days after randomization
Title
FMA-UE scores
Description
Difference in FMA-UE scores between baseline and 30 days after randomization.
Time Frame
30 days after randomization
Title
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores
Description
Difference in FMA-LE scores (range =0-34, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.
Time Frame
90 days after randomization
Title
National Institutes of Health Stroke Scale (NIHSS) scores
Description
Difference in NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 90 days after randomization.
Time Frame
90 days after randomization
Title
The Barthel index of activity of daily living (BI)
Description
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).
Time Frame
90 days after randomization
Title
Visual analogue scale (VAS) scores
Description
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).
Time Frame
90 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Gao, MD
Organizational Affiliation
Dongzhimen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital, Beijing University of Chinese Medicine
City
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs