Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment
The Effect of Huatuo Zaizao Pill on Neurological Function and Motor Recovery in Ischemic Stroke Patients During the Recovery Stage: a Open-labelled, Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study was to evaluate the improvement of limb motor function and nerve function of patients with HTZZ during stroke rehabilitation. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2021
CompletedStudy Start
First participant enrolled
May 31, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedNovember 29, 2024
November 1, 2024
2.1 years
May 27, 2021
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) measure spasticity. During the administration of MAS , the examiner passively moves the joint being tested and rates the perceived level of resistance in the muscle groups opposing the movement.It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
The change from baseline in Modified Ashworth Scale (MAS) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Secondary Outcomes (3)
National Institute of Health Stroke Scale (NIHSS )
The change from baseline in National institute of health stroke scale (NIHSS ) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Fugl-Meyer
The change from baseline in Fugl-Meye score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Barthel Index（BI）
The change from baseline in BI total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Study Arms (2)
HuaTuo ZaiZao group
EXPERIMENTALIn this arm, patients take 8g of HuatuoZaizao pill three times a day. Besides，participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks
Control group
SHAM COMPARATORparticipants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks
Interventions
Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.
It accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.
Eligibility Criteria
You may qualify if:
- Aged between 35 and 75 years old
- With a disease course between 2 weeks- 24weeks
- Meeting the diagnostic criteria of ischemic stroke
- Signed and dated written informed consent.
- ≤NIHSS score≤22
You may not qualify if:
- Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases
- Exclude Transient Ischemic Attack(TIA)
- Patients who are participating in clinical trials of other drugs within the past 1 month
- Pregnant or breastfeeding women
- Athletes, Epileptics, Allergic to this product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 10091, China
Related Publications (1)
Ding YQ, Zhao D, Chen X, Yuan HM, Mao LJ. Effect of Huatuo Zaizao Pill on Neurological Function and Limb Motor Recovery in Ischemic Stroke Patients During Convalescence: An Open-Labelled, Randomized Controlled Trial. Chin J Integr Med. 2025 Jun;31(6):483-489. doi: 10.1007/s11655-025-3928-4. Epub 2025 Apr 15.
PMID: 40232598DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants are randomly and evenly assigned to 2 groups using block randomization.Random numbers are generated by the stratified random method using the Statistical Analysis Software （SAS） statistical software and assigned by an independent statistician at the Good Clinical Practice Institute of XiYuan Hospital.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2021
First Posted
June 2, 2021
Study Start
May 31, 2021
Primary Completion
June 20, 2023
Study Completion
September 30, 2023
Last Updated
November 29, 2024
Record last verified: 2024-11