Research on reliability and validity and diagnostic efficacy evaluation of Qi Stagnation Syndrome and Its Subtype Syndrome Scale

Registration number:

ITMCTR2100005248

Date of Last Refreshed on:

2021-08-28

Date of Registration:

2021-08-28

Registration Status:

Prospective registration

Public title:

Research on reliability and validity and diagnostic efficacy evaluation of Qi Stagnation Syndrome and Its Subtype Syndrome Scale

English Acronym:

Scientific title:

Research on reliability and validity and diagnostic efficacy evaluation of Qi Stagnation Syndrome and Its Subtype Syndrome Scale

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100050545 ; ChiMCTR2100005248

Applicant:

Fang Ge

Study leader:

Hu Zhi-xi

Applicant telephone:

18719139564

Study leader's telephone:

13574812411

Applicant Fax:

Study leader's fax:

Applicant E-mail:

20202063@stu.hnucm.edu.cn

Study leader's E-mail:

003405@hnucm.edu.cn

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

Study leader's address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

College of Traditional Chinese Medicine of Hunan University of Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

HN-LL-KY-2021-021-01

Approved file of Ethical Committee:

View

Name of the ethic committee:

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

Date of approved by ethic committee:

2021/7/10 0:00:00

Contact Name of the ethic committee:

Yong Su-nan, Yu Pei

Contact Address of the ethic committee:

Conference Room, 10th Floor, Xingyuan Hotel, 95 Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Hunan University of Chinese Medicine

Primary sponsor's address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

Secondary sponsor:

Country:

China

Province:

Hunan

City:

Institution
hospital:

Hunan University of Chinese Medicine

Address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, China

Source(s) of funding:

Guangdong Provincial Government Fund

Target disease:

Depression, chronic non-atrophic gastritis, perimenopausal syndrome, breast cancer, coronary heart disease, chronic obstructive pulmonary disease

Target disease code:

Study type:

Observational study

Study design:

Cross-sectional

Study phase:

Others

Objectives of Study:

Evaluation of the reliability, validity and diagnostic efficacy of the Scale of Qi Stagnation Syndrome and its Subtype Syndrome provides a basis for the clinical quantitative diagnosis of Qi stagnation syndrome.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(1) Depression 1) Comply with the above-mentioned Western medical disease diagnostic criteria (mild and moderate depression) and TCM syndrome diagnostic criteria; 2) 20 points ≤ Hamilton Depression Rating Scale (HAMD-24) total score <35 points; 3) In line with the first episode of depression; 4) Patients with primary depression; 5) The vital signs are stable, conscientious, and expressive; 6) Those who have not taken Chinese or Western antidepressant drugs within 2 weeks; 7) 18 to 65 years old (including 18 and 65 years old), regardless of gender; Only those who meet the above seven items at the same time can be selected. (2) Chronic non-atrophic gastritis 1) Western medical standards: in line with the diagnostic criteria of chronic non-atrophic gastritis: mucosal erythema, mucosal bleeding points or plaques, with or without edema, and congestion and exudation can be seen under endoscopy; pathological diagnosis: Hp infection, etc. . 2) Diagnosis of gastrointestinal qi stagnation syndrome in traditional Chinese medicine: full of suffocation and pain, easily induced or aggravated by emotional insufficiency, emotional depression or irritability, bowel, qi, belching, hiccups, too much breath, appetite, belching Acid, vomiting, diarrhea, bitter mouth, lump in the abdomen, pale red tongue, dark tongue, thin white coating, thin yellow coating, greasy coating, white coating, stringy pulse, heavy pulse, slippery pulse. Table for dialectical diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the consensus opinion on the diagnosis and treatment of chronic non-atrophic gastritis with integrated traditional Chinese and western medicine (2017) and the consensus opinion on the diagnosis and treatment of chronic gastritis with traditional Chinese medicine (2017). (3) Perimenopausal syndrome 1) Western medical standards: refer to the diagnostic criteria of "International Clinical Practice Guidelines for Menopausal Syndrome (2020-10-11)" published by the World Federation of Chinese Medicine Societies and the Chinese Society of Chinese Medicine A group of syndromes with mainly nervous system dysfunction, accompanied by neuropsychological symptoms. Laboratory tests such as ovarian function evaluation are helpful for diagnosis. 2) Diagnosis of the syndrome of stagnation of liver and qi in traditional Chinese medicine: chest and hypogastric abdominal distension, fullness and pain, emotional depression or irritability, too much rest, foreign body sensation in the throat, dysmenorrhea, irregular menstruation, insomnia, qi, constipation, anorexia , Red tongue, dark tongue, thin white coating, thin yellow coating, stringy pulse, the scale will be used for dialectical diagnosis. 3) For the transformation of other syndromes from deficiency to reality, refer to "International Clinical Practice Guidelines of Traditional Chinese Medicine" (2020-10-11). (4) Breast cancer 1) Western medical standards: refer to the "Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2019 Edition)", and finally confirmed by pathological diagnosis. 2) Diagnosis of the syndrome of stagnation of liver and qi in traditional Chinese medicine: chest and hypogastric abdominal distension, fullness and pain, emotional depression or irritability, too much rest, foreign body sensation in the throat, dysmenorrhea, irregular menstruation, insomnia, qi, constipation, anorexia , Red tongue, dark tongue, thin white coating, thin yellow coating, stringy pulse, the scale will be used for dialectical diagnosis. 3) To transform other syndromes from false to actual, refer to "Traditional Chinese Medicine Surgery" edited by Chen Hongfeng, the tenth edition of the textbook. (5) Coronary heart disease 1) Western medical standards: refer to the "Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease" published by the Interventional Cardiology Group of the Cardiovascular Branch of the Chinese Medical Association in 2018 and the "Rational Use of Coronary Heart Disease Drugs" published by the National Health and Family Planning Commission Expert Committee on Rational Use in 2018 Guidelines (Second Edition)" Stable Coronary Heart Disease Diagnostic Criteria: (1) Chest discomfort, usually located behind the body of the sternum, can spread to the precordial area, with the palm size range, even across the front chest, the boundary is not very clear. It often radiates to the left shoulder, inner left arm, to the ring finger and little finger, or to the neck, pharynx, or jaw. (2) Chest pain is often compression, tightness, tightness, or a feeling of heaviness in the chest. It is sometimes described as a suffocation of the neck or a burning sensation behind the breastbone, but it is not as sharp as acupuncture or knife sticking. It can be accompanied by dyspnea or non-specific symptoms such as fatigue or weakness, dizziness, nausea, restlessness, or a sense of dying. When chest pain occurs, patients are often forced to stop their ongoing activities until the symptoms are relieved. (3) It usually lasts from a few minutes to more than 10 minutes, in most cases 3~5 minutes, rarely more than 30 minutes. (4) It is related to fatigue or emotional agitation. (5) Stress ECG: The ST segment of 0.06~0.08 s after the J point of more than 2 leads of the ECG during the stress exercise shows a horizontal or downward shift of ≥0.1 mV. However, in about 15% of SCAD patients, the ST-segment changes with diagnostic significance occur during the recovery period of the stress test. (6) Stress echocardiography: abnormal ventricular wall thickening is used as a sign of ischemia. (7) Patients with significant reduction in left ventricular function. (8) Myocardial perfusion imaging using positron emission tomography revealed that the ischemia range was >1%. (9) Patients with obvious stenosis found on coronary CT angiography (10) Patients with obvious stenosis on coronary angiography 2) Diagnosis of the syndrome of qi stagnation in the heart and pulse of traditional Chinese medicine: it is easy to induce or aggravate when suffering from emotional discomfort, shortness of breath, palpitations, emotional depression or irritability, too much rest, insomnia, little phlegm, pale red tongue, tongue texture For dark, thin and white fur, thin and greasy fur, stringy pulse, and heavy pulse, the scale will be used for diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the "Guidelines for the Diagnosis and Treatment of Stable Angina Pectoris of Coronary Heart Disease" issued by the Cardiovascular Branch of the Chinese Society of Chinese Medicine in 2020. (6) Chronic obstructive pulmonary disease 1) Western medical standards: refer to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" published by the Chronic Obstructive Pulmonary Disease Group of the Respiratory Medicine Branch of the Chinese Medical Association in 2021 and the "Guidelines for the Primary Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" published by the Chinese Medical Association in 2018 ( 2018)" Diagnosis criteria for chronic obstructive pulmonary disease: 1. Age ≥40 years old and/or history of exposure to risk factors, chronic cough, sputum expectoration, dyspnea and other symptoms. 2. Pulmonary function examination showed continuous airflow limitation, FEV1/FVC<70% after inhalation of bronchodilator, it is clear that there is continuous airflow limitation. 3. Comply with the diagnosis of chronic obstructive pulmonary disease, with cyanosis of the lips, nail bed, distended jugular vein, barrel chest, breathing frequency, breath sounds, rales, heart rate, heart rhythm, edema of both lower limbs, clubbing (toe). 2) TCM diagnosis of lung-qi stagnation closed syndrome: when suffering from emotional discomfort, it is easily induced or aggravated, wheezing, coughing, shortness of breath, emotional depression or irritability, too much breath, expectoration, little sputum, pale red tongue , Dark tongue, thin and white fur, thin and greasy fur, pulse string, pulse string, the scale will be used for dialectical diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the "International Clinical Practice Guidelines of Traditional Chinese Medicine: Chronic Obstructive Pulmonary Disease" issued by the World Federation of Chinese Medicine Societies.

Exclusion criteria:

(1) Depression 1) Existence of schizophrenia or depression after schizophrenia; 2) There is evidence that there is a etiological relationship between depressive episodes and physical diseases; 3) Pregnant or breastfeeding women who belong to patients who have relapsed depression; 4) Non-compliance with the inclusion criteria, or incomplete information affects the observer; Those that meet one of the above will be excluded. (2) Chronic non-atrophic gastritis Exclude atrophic gastritis and special types of gastritis. (3) Perimenopausal syndrome 1) Patients with severe liver and kidney dysfunction or tumors; 2) Pregnant or lactating women; 3) The researcher believes that there are other situations that are not suitable for participating in this research. (4) Breast cancer Exclude patients with non-breast cancer diseases, liver and kidney dysfunction, high lactation, systemic infectious diseases, and endocrine abnormalities. (5) Coronary heart disease 1) Patients with severe liver and kidney dysfunction or tumors; 2) Pregnant or lactating women; 3) The researcher believes that there are other situations that are not suitable for participating in this research. (6) Chronic obstructive pulmonary disease Exclude other heart and lung diseases (such as tuberculosis, pneumoconiosis, chronic obstructive pulmonary disease, bronchiectasis, lung cancer, heart disease, heart failure, chronic rhinitis, etc.) caused by cough, sputum or wheezing.

Study execute time:

From 2021-09-15

To      2023-12-31

Recruiting time:

From 2021-09-15

To      2023-12-31

Interventions:

600

Group:

Case series

Sample size:

Intervention:

Nil

Intervention code:

Total sample size : 600

Countries of recruitment
and research settings:

Country:

China

Province:

Changsha City

City:

Institution/hospital:

The First Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution:

Tertiary A hospital

Country:

China

Province:

Changsha City

City:

Institution/hospital:

Affiliated Hospital of Hunan Academy of Chinese Medicine

Level of the institution:

Tertiary A hospital

Country:

China

Province:

Changsha City

City:

Institution/hospital:

Hunan Provincial Brain Hospital

Level of the institution:

Tertiary A hospital

Outcomes:

Outcome:

Scale

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Blood

Tissue:

Fate of sample 

Preservation after use

Note:

Not yet recruiting

18
Min age years
85
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

None

Blinding:

IPD sharing:

Yes

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

The original data can be obtained from the research leader on reasonable request

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

Case Record Form

Data Managemen Committee:

Not yet

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above