MedDataX Logo

Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

NCT ID: NCT04910256

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants are randomly and evenly assigned to 2 groups using block randomization.Random numbers are generated by the stratified random method using the Statistical Analysis Software （SAS） statistical software and assigned by an independent statistician at the Good Clinical Practice Institute of XiYuan Hospital.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Huatuo Zaizao Pills

Intervention Type DRUG

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

Basic treatment

Intervention Type 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.

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

Group Type SHAM_COMPARATOR

Basic treatment

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Huatuo Zaizao Pills

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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Ding YQ, Zhao D, Chen X, Yuan HM, Mao LJ. Effect of Huatuo Zaizao Pill on Neurological Function and Limb Motor Recovery in Ischemic Stroke Patients During Convalescence: An Open-Labelled, Randomized Controlled Trial. Chin J Integr Med. 2025 Jun;31(6):483-489. doi: 10.1007/s11655-025-3928-4. Epub 2025 Apr 15.

Reference Type DERIVED
PMID: 40232598 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XiyuanH-huatuo zaizao pill

Identifier Type: -

Identifier Source: org_study_id