Clinical trial NCT04910256: Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Huatuo Zaizao pill
stroke rehabilitation
limb spasticity
motor recovery
traditional Chinese medicine
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, randomized controlled clinical trial. Eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to Hua Hua reconstruction group or control group at a ratio of 1:1. The treatment period is 12 weeks. The purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional Chinese medicine, and improve clinical efficacy. The main result is the changes of MAS scores 12 weeks days after taking the drug. The secondary result is the change in NIHSS, Fugl-Meyer and BI.

Eligibility criteria: Inclusion Criteria:

* 1.Aged between 35 and 75 years old
* 2.With a disease course between 2 weeks- 24weeks
* 3.Meeting the diagnostic criteria of ischemic stroke
* 4.Signed and dated written informed consent.
* 5.4≤NIHSS score≤22

Exclusion Criteria:

* 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases
* 2.Exclude Transient Ischemic Attack(TIA)
* 3.Patients who are participating in clinical trials of other drugs within the past 1 month
* 4.Pregnant or breastfeeding women
* 5.Athletes, Epileptics, Allergic to this product

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 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:
measure: National Institute of Health Stroke Scale (NIHSS )
timeFrame: 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]
measure: Fugl-Meyer
timeFrame: The change from baseline in Fugl-Meye score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
measure: Barthel Index（BI）
timeFrame: The change from baseline in BI total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: