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

Health Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516629
• Other study ID #: YM105101E
• Status: Completed
• Start date: March 21, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2018
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Status
• Syndrome

Intervention

Diagnostic Test:
• heart rate variability, pulse diagnosis device
check heart rate and pulse rate

Locations

Country	Name	City	State
Taiwan	National Yang-Ming university	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	heart rate variability	a non-invasive method to evaluate autonomic nervous activity in human	immediately after interview