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NCT Number: NCT04910256

Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 10091, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Huatuo Zaizao Pills

Drug

Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.

Basic treatment

Other

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.

Primary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: 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]

    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.

Secondary outcomes

  1. National Institute of Health Stroke Scale (NIHSS )

    Time frame: 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]

    The National Institutes of Health Stroke Scale (NIHSS) is a 15-item measure of the effect of acute stroke on a variety of areas including level of consciousness, neglect, motor strength, facial palsy, ataxia, dysarthria, and sensory loss.

  2. Fugl-Meyer

    Time frame: The change from baseline in Fugl-Meye score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]

    The Fugl-Meyer Assessment of Sensorimotor Impairment (FM) is one of the first scales developed to quantitatively measure the recovery from hemiplegic stroke. It assesses recovery in five domains, including motor functioning of the upper and lower extremities, balance, sensation, joint range of motion, and joint pain in post-stroke patients. Each task is scored on a scale of 0-2, with 0 indicating the patient cannot perform the task and 2 indicating the patient can fully perform the task.

  3. Barthel Index（BI）

    Time frame: The change from baseline in BI total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]

    The BI is a test used in healthcare to evaluate the people's daily self care activities.

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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