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Advantages and clinical evaluation of acupuncture combined with medicine in the treatment of ischemic stroke

Registration number：

ITMCTR2200005720

Date of Last Refreshed on：

2022-03-15

Date of Registration：

2022-03-15

Registration Status：

Prospective registration

Public title：

Advantages and clinical evaluation of acupuncture combined with medicine in the treatment of ischemic stroke

English Acronym：

Scientific title：

Advantages and clinical evaluation of acupuncture combined with medicine in the treatment of ischemic stroke

Scientific title acronym：

Study subject ID：

2022SK2014

The registration number of the Partner Registry or other register：

ChiCTR2200057633 ; ChiMCTR2200005720

Applicant：

Huang qian

Study leader：

Deng kaiwen

Applicant telephone：

18373918198

Study leader's telephone：

13875974085

Applicant Fax：

Study leader's fax：

Applicant E-mail：

18373918198@163.com

Study leader's E-mail：

940360299@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Study leader's address：

No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Applicant postcode：

410007

Study leader's postcode：

410007

Applicant's institution：

The First Affiliated Hospital of Hunan University of traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

HN-LL-KY-2021-029-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Hunan University of traditional Chinese Medicine

Date of approved by ethic committee：

2022/1/14 0:00:00

Contact Name of the ethic committee：

sunan Yong、pei Yu

Contact Address of the ethic committee：

No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Contact phone of the ethic committee：

0731-85600565

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital of Hunan University of traditional Chinese Medicine

Primary sponsor's address：

No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Secondary sponsor：

Country：

China

Province：

Hunan Province

City：

Changshang City

Institution
hospital：

The First Hospital of Hunan University of Chinese Medicine

Address：

No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Source(s) of funding：

Major R & D projects in Hunan Province:2022SK2014

Target disease：

ischemic stroke

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The purpose of this study is to observe the clinical efficacy and mechanism of Buyang Huanwu Decoction, acupuncture and the combination of acupuncture and medicine on patients with ischemic stroke, and to evaluate the adverse reaction rate of the two treatment methods, so as to provide a certain basis for clinical optimization of the treatment scheme of ischemic stroke. To observe the effectiveness and safety of the combination of acupuncture and medicine in the treatment of ischemic stroke. At the same time, through the clinical real world, non clinical quantitative pharmacological methods, clinical efficacy evaluation and Application Research of the combination of acupuncture and medicine in the treatment of ischemic stroke, to clarify the mechanism and scientific principle of clinical treatment advantage of the combination of acupuncture and medicine in the treatment of ischemic stroke; It has important economic, social and academic value to establish its clinical evaluation method and obtain the optimal clinical treatment scheme to solve the physical and mental pain of patients.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) It meets the diagnostic criteria of traditional Chinese and Western medicine for ischemic stroke, which is acute stage and recovery stage; (2) Meet the diagnostic criteria of qi deficiency and blood stasis in traditional Chinese medicine; (3) Age: 35 ~ 80 years old; (4) Mild and moderate cerebral infarction, no mental disorder, relatively stable condition, relatively few basic diseases and relatively few basic drugs; (5) Onset time ≤ 6 months; (6) Consent to treatment, express informed consent to this study and sign the informed consent form.

Exclusion criteria：

(1) It does not meet the diagnostic criteria of traditional Chinese and Western medicine for ischemic stroke; (2) The course of disease is more than 6 months (3) Intracerebral hemorrhage, heart, liver, kidney and other organ failure; (4) The condition is unstable and critical, and there are relatively many basic drugs; (5) Serious cognitive impairment or mental illness, unable to cooperate with treatment; (6) Pregnant women, lactating women and pregnant women; (7) Allergic to drug ingredients; (8) Patients with hemorrhagic diseases and immune system diseases; (9) Those who cannot tolerate acupuncture; (10) Coagulation dysfunction; (11) Blood pressure ≥ 180 / 105 mmHg.

Study execute time：

From 2022-01-14

To      2024-12-31

Recruiting time：

From 2022-03-01

To      2024-06-30

Interventions：

30

Group：

Acupuncture group

Sample size：

Intervention：

Acupuncture

Intervention code：

30

Group：

Acupuncture and medicine group

Sample size：

Intervention：

Acupuncture + Buyang Huanwu Decoction

Intervention code：

30

Group：

Traditional Chinese medicine group

Sample size：

Intervention：

Buyang Huanwu Decoction

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Hunan

City：

Changsha

Institution/hospital：

The First Affiliated Hospital of Hunan University of traditional Chinese Medicine

Level of the institution：

first class hospital

Outcomes：

Outcome：

Barthel Index (BI) rating scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Standard scale for diagnosis and efficacy evaluation of stroke

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Stroke clinical neurological deficit scale (NDS)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

35
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)：

ake the simple randomization method, input the sample size into concise statistical analysis, and obtain the random number table. When qualified cases enter the trial, enter the corresponding group in the random number table according to the specific order of entry. The patients were randomly assigned to acupun

Blinding：

IPD sharing：

Yes

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

No sharing

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

Case Record Form, CRF

Data Managemen Committee：

Yes

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

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