Completed

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

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What is being tested

Huatuo Zaizao Pills

+ Basic treatment

DrugOther
Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 35 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 31, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleThe 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
NCT04910256
Principal SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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

Group II

Sham
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, ChinaOpen Xiyuan Hospital, China Academy of Chinese Medical Sciences in Google Maps
CompletedOne Study Center