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

NCT05666531 | Unknown

• 1 other identifier: 2022-1-4301
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia; Chronic Gastritis

Keywords

Blood pressure in both arms; syndrome differentiation; liver-spleen disharmony; efficacy evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pulse diagnosis information

  10minutes

• Pittsburgh Sleep Quality Index (PSQI）

  5minutes

• Hamilton Anxiety Scale (HAMA)

  5minutes

• Hamilton Depression Scale (HAMD)

  5minutes

• Gastrointestinal Symptom Scale

  5minutes

Study Arms (3)

Healthy people

The physical examination ruled out the disease

Chronic gastritis

The endoscopic diagnosis is consistent with chronic gastritis or self-reported stomachache

Insomnia

The Pittsburgh Sleep Quality Index Scale was measured and assessed as meeting a diagnosis of insomnia disorder or self-reported insomnia for more than three months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Physical examination center and Hospital Outpatient Clinic

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Liyun He: lead
• Beijing University of Chinese Medicine: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Affiliated Hospital of Inner Mongolia Minzu University: collaborator
• Hohhot Hospital of Mongolian Medicine and TCM: collaborator

Study Sites (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Liyun HE, Dr.

CONTACT

13581770875; hely3699@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of TCM Clinical Efficacy Evaluation Center

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)