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

Not Applicable

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

• Registration Number: ITMCTR2100005248
• Lead Sponsor: Hunan University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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, da

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 & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scale;