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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04516629
Enrollment
100
Registered
2020-08-18
Start date
2017-03-21
Completion date
2017-12-30
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Status

Keywords

subhealth, obese, hypertension, sleep apnea syndrome, fatigue, TCM syndrome, physiological signal monitor system

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.

Interventions

DIAGNOSTIC_TESTheart rate variability, pulse diagnosis device

check heart rate and pulse rate

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Sub-optimal Health Status Questionnaire-25immediately after interviewminimum (0) and maximum (100) values; score more than 35 is defined as sub-optimal health

Secondary

MeasureTime frameDescription
heart rate variabilityimmediately after interviewa non-invasive method to evaluate autonomic nervous activity in human

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026