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Randomized and controlled clinical study on the treatment of acute myocardial infarction complicated with acute upper gastrointestinal bleeding with Wenyang Zhixue Decoction based on "Spleen governing blood"

Registration number：

ITMCTR2024000648

Date of Last Refreshed on：

2024-11-03

Date of Registration：

2024-11-03

Registration Status：

Retrospective registration

Public title：

Randomized and controlled clinical study on the treatment of acute myocardial infarction complicated with acute upper gastrointestinal bleeding with Wenyang Zhixue Decoction based on "Spleen governing blood"

English Acronym：

Randomized and controlled clinical study on the treatment of acute myocardial infarction complicated with acute upper gastrointestinal bleeding with Wenyang Zhixue Decoction based on "Spleen governing blood"

Scientific title：

Randomized and controlled clinical study on the treatment of acute myocardial infarction complicated with acute upper gastrointestinal bleeding with Wenyang Zhixue Decoction based on "Spleen governing blood"

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xiaoya Wang

Study leader：

Xingjiang Xiong

Applicant telephone：

18536842726

Study leader's telephone：

15801463736

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wangxiaoya2726@163.com

Study leader's E-mail：

5administration@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.5 North Line Pavilion Xicheng District Beijing

Study leader's address：

No.5 North Line Pavilion Xicheng District Beijing

Applicant postcode：

100053

Study leader's postcode：

100053

Applicant's institution：

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2024-173-KY

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/9/2 0:00:00

Contact Name of the ethic committee：

Jie Qiao

Contact Address of the ethic committee：

No.5 North Line Pavilion Xicheng District Beijing

Contact phone of the ethic committee：

010-88001552

Contact email of the ethic committee：

gamhec@126.com

Primary sponsor：

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Primary sponsor's address：

No.5 North Line Pavilion Xicheng District Beijing

Secondary sponsor：

Country：

china

Province：

Beijing

City：

Xicheng District

Institution
hospital：

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Address：

No.5 North Line Pavilion Xicheng District Beijing

Source(s) of funding：

Joint research project of China Science and Technology Development Center of Traditional Chinese Medicine (Talent Exchange Center of National Administration of Traditional Chinese Medicine)

Target disease：

acute myocardial infarction complicated with acute upper gastrointestinal bleeding

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

1. To clarify the TCM syndrome differentiation rules and key theoretical issues of acute myocardial infarction complicated with acute upper gastrointestinal bleeding. 2. To reveal the evidence-based basis of loess Decoction in the treatment of acute myocardial infarction complicated with acute upper gastrointestinal hemorrhage and to form high-quality and internationally recognized clinical evidence. 3. To explore the difference between the therapeutic effect of TCM formula granules and traditional decoction pieces and provide a reference for the clinical dosage of TCM formula granules. 4. To detect and compare the content of active components of Rehmannia and ejiao in compound water decoction and granule compound solution.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Patients who meet the above Western diagnostic criteria for acute myocardial infarction and acute upper gastrointestinal bleeding as well as the traditional Chinese diagnostic criteria for Yang deficiency blood syndrome. ② Patients were selected to be classified as moderate risk low risk and very low risk for acute upper gastrointestinal bleeding and those who did not need to or could not refrain from water fasting after assessment. ③ Aged 18-75 years old; ④ Clear consciousness able to understand the content of the scale good compliance; (5) Patients and their family members were aware of the condition and treatment plan and voluntarily participated in the study; Voluntarily sign informed consent and cooperate with treatment.

Exclusion criteria：

①The risk of acute upper gastrointestinal bleeding was divided into extremely high risk patients high-risk patients requiring emergency rescue or patients with strict water fasting and other requirements; ② Those who met the inclusion criteria but did not follow the treatment plan after inclusion; ③ Unable to cooperate with the interviewer due to language communication barriers or other reasons.

Study execute time：

From 2024-09-02

To      2025-02-28

Recruiting time：

From 2024-09-03

To      2024-12-31

Interventions：

30

Group：

decoction

Sample size：

Intervention：

Oral traditional decoction of Loess decoction twice a day for 7 consecutive days; Conventional western medicine treatment

Intervention code：

30

Group：

granula

Sample size：

Intervention：

Oral administration of Loess Decoction traditional Chinese medicine formula granules, twice a day for 7 consecutive days; Conventional western medicine treatment

Intervention code：

30

Group：

1/2 granula

Sample size：

Intervention：

Oral administration of 1/2 dose of Huanghuangtang Traditional Chinese medicine formula granule, twice a day for 7 consecutive days; Conventional western medicine treatment

Intervention code：

30

Group：

Placebo

Sample size：

Intervention：

Placebo granules were taken orally twice a day for 7 days; Conventional western medicine treatment

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

china

Province：

Beijing

City：

----

Institution/hospital：

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Level of the institution：

Top three hospital

Outcomes：

Outcome：

How long it takes for the bleeding to stop

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

life quality score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Glasgow-Blatchford bleeding score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

heart rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

BUN

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hemoglobin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

major adverse cardiac events

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome integral

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The random method adopts central random the random scheme is completed by a third party and the random scheme is hidden. Random allocation schemes are generated by the PROC PLAN program of SAS 9.0 software

Blinding：

IPD sharing：

Yes

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：

In this study self-designed CRF table was used. Use Medidata Rave EDC as an EDC for data management

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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