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Completed

NCT Number: NCT04516629

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

heart rate variability, pulse diagnosis device

Diagnostic Test

check heart rate and pulse rate

Primary outcomes

  1. Sub-optimal Health Status Questionnaire-25

    Time frame: immediately after interview

    minimum (0) and maximum (100) values; score more than 35 is defined as sub-optimal health

Secondary outcomes

  1. heart rate variability

    Time frame: immediately after interview

    a non-invasive method to evaluate autonomic nervous activity in human

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2020
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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