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

NCT04516629 | Completed

• 1 other identifier: YM105101E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Status

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• heart rate variability

  immediately after interview

Study Arms (1)

Experimental

subjects with sub-health status

Diagnostic Test: heart rate variability, pulse diagnosis device

Interventions

heart rate variability, pulse diagnosis device DIAGNOSTIC_TEST

check heart rate and pulse rate

Experimental

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming university

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Obesity; Hypertension; Sleep Apnea Syndromes; Fatigue

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: August 18, 2020
• Study Start: March 21, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 18, 2020

Record last verified: 2018-10

Locations

TW (1)