Ischemic StrokePEARLNCT06049498
Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke
A study testing Mongolian Medicine ZhenBao Pills in people with Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mongolian Medicine ZhenBao Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, 100700
About this study
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.
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.
Read the detailed description
The study is a randomized, double-blinded, placebo-controlled, multi-center trial.
- Conditions
- Ischemic Stroke
- Being tested
- Mongolian Medicine ZhenBao Pills, Mongolian Medicine ZhenBao Pills Placebo
- Keywords
- ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mongolian Medicine ZhenBao PillsDrug
Mongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day.
Mongolian Medicine ZhenBao Pills PlaceboDrug
Mongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Mongolian Medicine ZhenBao Pills group | Experimental | Experimental group Receives: Drug: Mongolian Medicine ZhenBao Pills |
| Mongolian Medicine ZhenBao Pills Placebo-controlled group | Placebo comparator | Placebo-controlled group Receives: Drug: Mongolian Medicine ZhenBao Pills Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after randomization
Secondary outcomes (6)
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.)
Measured: 90 days after randomization
FMA-UE scores
Difference in FMA-UE scores between baseline and 30 days after randomization.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 90 days after randomization
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).
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jan 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, Principal investigator, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049498
- Sponsor's protocol ID
- HX-DZM-202227
- Acronym
- PEARL
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06049498
- Acronym / sponsor ID
- PEARL / HX-DZM-202227
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, Mongolian Medicine ZhenBao Pills, efficacy, safety, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mongolian Medicine ZhenBao Pills group | Experimental | Drug: Mongolian Medicine ZhenBao PillsExperimental group |
| Mongolian Medicine ZhenBao Pills Placebo-controlled group | Placebo comparator | Drug: Mongolian Medicine ZhenBao Pills PlaceboPlacebo-controlled group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mongolian Medicine ZhenBao PillsMongolian Medicine ZhenBao Pills, orally, 15 pills each time, twice a day. | Drug | Mongolian Medicine ZhenBao Pills group |
| Mongolian Medicine ZhenBao Pills PlaceboMongolian Medicine ZhenBao Pills placebo, orally, 15 pills each time, twice a day. | Drug | Mongolian Medicine ZhenBao Pills Placebo-controlled group |
Primary outcome
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
Time frame: 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.
6 secondary outcomes
Modified Rankin scale (mRS) scores
Time frame: 90 days after randomization
FMA-UE scores
Time frame: 30 days after randomization
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores
Time frame: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS) scores
Time frame: 90 days after randomization
The Barthel index of activity of daily living (BI)
Time frame: 90 days after randomization
Visual analogue scale (VAS) scores
Time frame: 90 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gao, MD principal investigator
Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mongolian Medicine ZhenBao Pills in people with Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.