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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666531
• Other study ID #: 2022-1-4301
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: China Academy of Chinese Medical Sciences
• Contact: Liyun HE, Dr.
• Phone: 13581770875
• Email: hely3699[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Gastritis
• Gastritis
• Insomnia

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital, Capital Medical University	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Liyun He	Affiliated Hospital of Inner Mongolia Minzu University, Beijing Shijitan Hospital, Capital Medical University, Beijing University of Chinese Medicine, Hohhot Hospital of Mongolian Medicine and TCM

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure measurement in both arms	The systolic blood pressure, diastolic blood pressure and pulse rate of the left and right upper arms were simultaneously measured by a standard dual-arm electronic sphygmomanometer. A total of 6 data were collected. A total of 30 data were collected and measured for 5 times without interruption, which was used to judge the functional balance state of "Zang-fu regional tissues" in human body.	5minutes
Secondary	Pulse diagnosis information	The data collected by tongue pulse analyzer were used as one of the diagnostic information of hepatic and splenic dysregulation	10minutes
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI),used to assess the actual sleep status in the last 1 month.The total score ranges from 0 to 2l, with higher scores indicating poorer sleep quality	5minutes
Secondary	Hamilton Anxiety Scale (HAMA)	Hamilton Anxiety Scale (HAMA),used to assess the severity of anxiety symptoms.The total score ranges from 0 to 56, with higher scores indicating more anxiety.	5minutes
Secondary	Hamilton Depression Scale (HAMD)	Hamilton Depression Scale (HAMD), used to assess the severity of depression.The total score ranges from 0 to 96, with higher scores indicating more severe depression.	5minutes
Secondary	Gastrointestinal Symptom Scale	Gastrointestinal Symptom Rating Scale (GSRS),used to assess gastrointestinal function for nearly one week.The total score ranges from 0 to 112, with higher scores indicating more severe gastrointestinal symptoms.	5minutes
Secondary	Grade table of main disorders of liver and spleen	Grade table of main disorders of liver and spleen, used to assess the severity of the disorder of liver and spleen. The total score ranges from 0 to 24, with higher scores indicating more severe disorder of liver and spleen.	5minutes