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

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.

Study Overview

• Status: Completed
• Conditions: Health Status
• Intervention / Treatment: Diagnostic test: heart rate variability, pulse diagnosis device

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study enrolled individuals aged between 20 and 39 years based on previous studies, which showed that SHS is most prevalent in people aged 20 to 39 years. Individuals who conformed to A+B+D or A+C+D (described below) and who had not been diagnosed as having a disease by personnel practicing Western medicine were defined as having SHS. Individuals who did not meet the criteria for SHS and who had not been diagnosed as having a disease by Western medicine were defined as healthy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; subjects with sub-health status	Diagnostic test: heart rate variability, pulse diagnosis device; check heart rate and pulse rate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: fatigue; hypertension; sleep apnea syndrome; obese; TCM syndrome; subhealth; physiological signal monitor system
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: YM105101E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No