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The effect of Huatuo Zao Pill on limb motor function after stroke

Registration number：

ITMCTR2024000430

Date of Last Refreshed on：

2024-09-13

Date of Registration：

2024-09-13

Registration Status：

Retrospective registration

Public title：

The effect of Huatuo Zao Pill on limb motor function after stroke

English Acronym：

Scientific title：

A Randomized controlled clinical study of Huatuo Zazao Pill in the treatment of limb motor dysfunction function after stroke

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zheng Mingcui

Study leader：

Li Yabin

Applicant telephone：

13042021802

Study leader's telephone：

18298358253

Applicant Fax：

Study leader's fax：

Applicant E-mail：

13042021802@163.com

Study leader's E-mail：

424068699@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

32 Yunpu 1st Road Huangpu District Guangzhou City Guangdong Province

Study leader's address：

No.53 Dingxi Road Chengguan District Lanzhou City

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangzhou Baiyun Mountain Qixing Pharmaceutical Co. LTD

Approved by ethic committee：

Approved No. of ethic committee：

gsskfzxyy-11-lw-2024001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Gansu Provincial Rehabilitation Center Hospital

Date of approved by ethic committee：

2024/8/28 0:00:00

Contact Name of the ethic committee：

Zhao guining

Contact Address of the ethic committee：

No.53 Dingxi Road Chengguan District Lanzhou City

Contact phone of the ethic committee：

13993198161

Contact email of the ethic committee：

gskfzxkjk@163.com

Primary sponsor：

Gansu Provincial Rehabilitation Center Hospital

Primary sponsor's address：

No.53 Dingxi Road Chengguan District Lanzhou City

Secondary sponsor：

Country：

China

Province：

Gansu province

City：

Institution
hospital：

Gansu Provincial Rehabilitation Center Hospital

Address：

No.53 Dingxi Road Chengguan District Lanzhou City

Source(s) of funding：

Guangzhou Baiyun Mountain Qixing Pharmaceutical Co. LTD

Target disease：

stroke

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

To evaluate the effectiveness of Huatuo Zaizao pill in the treatment of limb motor dysfunction after stroke and its influence on the walking ability of patients.

Description for medicine or protocol of treatment in detail：

The experimental group received routine stroke treatment and comprehensive rehabilitation training (passive training motor and sensory training active training physical therapy etc.) and was orally loaded with Huatuo Zao Pill 8g/ time 3 times/day for 90 days. The control group received routine stroke treatment comprehensive rehabilitation training (passive training motor sensory training active training physical therapy etc.) and continued medication for 90 days.

Inclusion criteria

 meeting the diagnostic criteria of Western medicine the patient was confirmed as cerebral infarction or cerebral hemorrhage by craniocerebral CT/MRI;  stroke was the primary unilateral onset duration ≤ 7 days duration ≤ 90 days age ≤ 30 years age ≤ 80 years;  Stable vital signs conscious no obvious cognitive impairment can cooperate with the completion of treatment and evaluation;  Brunnstrom motor function of hemiplegia was evaluated as stage Ⅰ to Ⅴ;  sign the informed consent and participate in the clinical trial voluntarily.

Exclusion criteria：

 myodystonia not caused by stroke;  Have a previous motor disability such as rheumatoid arthritis limb surgery joint deformity multiple sclerosis spinal cord injury or neuromuscular disease that affects limb sensation or movement;  Patients with severe heart liver kidney endocrine diseases or secondary epilepsy or mental illness;  Recent use of muscle relaxants or traditional Chinese and western sedatives;  Patients whose Mini-Mental State Examination (MMSE) score is ≤ 9 and cannot cooperate with examination and treatment;  allergic to the investigational drug and its components;  Pregnant or lactating women;  The researchers did not consider it appropriate to participate.

Study execute time：

From 2024-09-01

To      2025-09-01

Recruiting time：

From 2024-09-01

To      2025-09-01

Interventions：

36

Group：

experimental group

Sample size：

Intervention：

routine stroke treatment， comprehensive rehabilitation training+Huatuo zaizao pills

Intervention code：

36

Group：

control group

Sample size：

Intervention：

routine stroke treatment+comprehensive rehabilitation training

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

Gansu province

City：

Institution/hospital：

Gansu Provincial Rehabilitation Center Hospital

Level of the institution：

Class III Class A hospital

Outcomes：

Outcome：

MWS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IEMG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

MAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

MBI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

FMA

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Recruiting

30
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Statistics experts use SAS software to generate random numbers

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

No

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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