Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects

Sponsor

National Yang Ming University (Other)

Overall Status

Completed

CT.gov ID

NCT04516629

Collaborator

(none)

100

Enrollment

Location

9.3

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Suboptimal health status (SHS) is a dynamic state potential clinical stage or prior psychosomatic disease stage during which people have not been diagnosed with a disease, but they have risk factors for illness and have tendency to develop diseases. The term refers to an existing condition of ill health that could lead to a pathologic condition but could also be eliminated, enabling the individual in question to return to a state of good health. Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, early TCM-based intervention can improve the health status of people with SHS. People with SHS often experience such nonspecific symptoms as fatigue; such symptoms are typical of SHS from the perspective of TCM. The present study investigated people with SHS and fatigue as their primary symptom. All enrolled participants completed a physical questionnaire, after which their physiological parameters were monitored using a cloud physiological signal monitoring system to investigate correlations with TCM patterns. Methods: The participants first completed a body constitution questionnaire, the WHO Quality of Life questionnaire, the SHSQ-25 questionnaire, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index, and subsequently underwent sphygmography to determine their pulse patterns. Analyses of pulse waves were presented in relation to the spectral energy ratio (SER), and SER10 scores represented subtle changes in internal organ blood flow; 13-50-Hz spectrum analysis for pulse delineated any flow energy deviation in organs.

Condition or Disease	Intervention/Treatment	Phase
Health Status	Diagnostic Test: heart rate variability, pulse diagnosis device

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects

Actual Study Start Date :

Mar 21, 2017

Actual Primary Completion Date :

Dec 30, 2017

Actual Study Completion Date :

Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental subjects with sub-health status	Diagnostic Test: heart rate variability, pulse diagnosis device check heart rate and pulse rate

Arm

Intervention/Treatment

Experimental

subjects with sub-health status

Diagnostic Test: heart rate variability, pulse diagnosis device

check heart rate and pulse rate

Outcome Measures

Primary Outcome Measures

Sub-optimal Health Status Questionnaire-25 [immediately after interview]
minimum (0) and maximum (100) values; score more than 35 is defined as sub-optimal health

Secondary Outcome Measures

heart rate variability [immediately after interview]
a non-invasive method to evaluate autonomic nervous activity in human

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Fatigue combined with one or more of the following symptoms of insomnia and higher dreaming frequency, irritability and short temperedness, forgetfulness, chest tightness, lack of concentration, or loss of memory (assessed using the Suboptimal Health Status Questionnaire-25 [SHSQ-25]).
Body mass index (BMI) between 25 and 30 kg/m2.
Resting blood pressure measured as 130-139/80-89 mmHg on more than three occasions in 1 week.
SHSQ-25 score of ≧35

Exclusion Criteria:

Individuals diagnosed as having a chronic condition by Western medicine, including hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, and coronary heart disease.
Individuals diagnosed as having a mental illness by Western medicine.
Individuals diagnosed with cancer.