Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

November 25, 2024 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 10091
        • Xiyuan Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HuaTuo ZaiZao group
In 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
Drug: Huatuo Zaizao Pills
Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.
Other: Basic treatment
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.
Sham Comparator: Control group
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
Other: Basic treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XiyuanH-huatuo zaizao pill

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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