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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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