Clinical trial NCT04516629: Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects
Official title: Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Status
Keywords: subhealth
obese
hypertension
sleep apnea syndrome
fatigue
TCM syndrome
physiological signal monitor system
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sub-optimal Health Status Questionnaire-25
timeFrame: immediately after interview
Secondary outcomes:
measure: heart rate variability
timeFrame: immediately after interview
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming university
Study officials:
References: