Clinical trial NCT05666531: Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
Official title: Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insomnia
Chronic Gastritis
Keywords: Blood pressure in both arms
syndrome differentiation
liver-spleen disharmony
efficacy evaluation
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: Beijing Shijitan Hospital, Capital Medical University
name: Affiliated Hospital of Inner Mongolia Minzu University
name: Hohhot Hospital of Mongolian Medicine and TCM
First posted: 2022-12-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physical examination center and Hospital Outpatient Clinic

Brief summary: By combining the measurement of blood pressure in both arms with the information of the four diagnoses of TCM, we try to form a diagnostic model of "five diagnoses combined with ginseng" based on TCM Zang-fu syndrome differentiation. It can further objectify and visualize the fuzzy four diagnostic indicators of TCM. In order to solve the problem of data differentiation of TCM four diagnoses, and optimize the five diagnoses of TCM conjunctive index, explore the establishment of TCM intelligent diagnosis and treatment and contact evaluation computer system


Eligibility criteria: Inclusion Criteria:

Case inclusion Criteria:

* Patients were treated with epigastric pain and / or insomnia, which met the above diagnostic criteria for diseases, liver and spleen;
* diagnostic criteria for diseases, liver and spleen;
* Age 18-65 years old;
* It can combine mild and moderate depression, anxiety Sign the informed consent form.

Healthy control inclusion criteria:

* PSQI \< 5 points;
* No hypertension, diabetes, hyperlipidemia, coronary heart disease and other underlying diseases;
* No depression, anxiety, malignant tumor, syphilis, HIV and other infectious diseases;
* Over 18 years of age;
* Volunteer to participate in this study, cooperate with the measurement of blood pressure in both arms, and sign the informed consent.

Exclusion Criteria:

Case exclusion criteria:

* Patients with insomnia disorder caused by uneffectively controlled or serious diseases, such as malignant tumor, persistent pain, cardiovascular and cerebrovascular diseases, endocrine diseases, etc.;
* patients with severe depression and mental illness;
* Pregnant and lactation patients.

Healthy controls exclusion criteria:

* sleep apnea syndrome or restless leg syndrome and other sleep disorders;
* Pregnant and lactation;
* Abnormal symptoms and abnormal tongue pulse occur in the body, such as facial acne, dysmenorrhea, thick and greasy tongue coating, loose stools, fat tongue, teeth marks and tongue.

Primary outcomes:
measure: Blood pressure measurement in both arms
timeFrame: 5minutes
Secondary outcomes:
measure: Pulse diagnosis information
timeFrame: 10minutes
measure: Pittsburgh Sleep Quality Index (PSQI）
timeFrame: 5minutes
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 5minutes
measure: Hamilton Depression Scale (HAMD)
timeFrame: 5minutes
measure: Gastrointestinal Symptom Scale
timeFrame: 5minutes
measure: Grade table of main disorders of liver and spleen
timeFrame: 5minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
Study officials:
References: