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

Study Overview
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Brief Summary
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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.

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

Conditions
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Health Status

Intervention / Treatment
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* Diagnostic Test: heart rate variability, pulse diagnosis device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>subjects with sub-health status | Diagnostic Test: heart rate variability, pulse diagnosis device<br>* check heart rate and pulse rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-optimal Health Status Questionnaire-25 | minimum (0) and maximum (100) values; score more than 35 is defined as sub-optimal health | immediately after interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | a non-invasive method to evaluate autonomic nervous activity in human | immediately after interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subhealth, obese, hypertension, sleep apnea syndrome, fatigue, TCM syndrome, physiological signal monitor system