NCT06049498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

July 24, 2023

Last Update Submit

September 15, 2023

Conditions

Ischemic Stroke

Keywords

ischemic strokeMongolian Medicine ZhenBao Pillsefficacysafetyrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Modified Rankin scale (mRS) scores

    90 days after randomization

  • FMA-UE scores

    30 days after randomization

  • The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores

    90 days after randomization

  • National Institutes of Health Stroke Scale (NIHSS) scores

    90 days after randomization

  • The Barthel index of activity of daily living (BI)

    90 days after randomization

  • +1 more secondary outcomes

Study Arms (2)

Mongolian Medicine ZhenBao Pills group

EXPERIMENTAL

Experimental group

Drug: Mongolian Medicine ZhenBao Pills

Mongolian Medicine ZhenBao Pills Placebo-controlled group

PLACEBO COMPARATOR

Placebo-controlled group

Drug: Mongolian Medicine ZhenBao Pills Placebo

Interventions

Mongolian Medicine ZhenBao PillsDRUG

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

Mongolian Medicine ZhenBao Pills group
Mongolian Medicine ZhenBao Pills PlaceboDRUG

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

Mongolian Medicine ZhenBao Pills Placebo-controlled group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, 100700, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ying Gao, MD

    Dongzhimen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2023

First Posted

September 22, 2023

Study Start

October 1, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

CN(1)