Health StatusNCT04516629
Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects
An observational study of Health Status, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status
- What is being tested?
- heart rate variability, pulse diagnosis device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Mar 2017to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- heart rate variability, pulse diagnosis device
- Keywords
- subhealth, obese, hypertension, sleep apnea syndrome, fatigue, TCM syndrome, physiological signal monitor system
- Medical subject headings
- Obesity, Hypertension, Sleep Apnea Syndromes, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability, pulse diagnosis deviceDiagnostic test
check heart rate and pulse rate
| Study group | Role | What they receive |
|---|---|---|
| Experimental | subjects with sub-health status Receives: Diagnostic Test: heart rate variability, pulse diagnosis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-optimal Health Status Questionnaire-25
minimum (0) and maximum (100) values; score more than 35 is defined as sub-optimal health
Measured: immediately after interview
Secondary outcomes (1)
heart rate variability
a non-invasive method to evaluate autonomic nervous activity in human
Measured: immediately after interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start21 Mar 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516629
- Sponsor's protocol ID
- YM105101E
- Status last verified
- Oct 2018
- First submitted
- 18 Mar 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects
- ClinicalTrials.gov ID
- NCT04516629
- Acronym / sponsor ID
- YM105101E
- Conditions
- Health Status
- Keywords
- subhealth, obese, hypertension, sleep apnea syndrome, fatigue, TCM syndrome, physiological signal monitor system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Diagnostic Test: heart rate variability, pulse diagnosis devicesubjects with sub-health status |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate variability, pulse diagnosis devicecheck heart rate and pulse rate | Diagnostic test | Experimental |
Primary outcome
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
1 secondary outcome
heart rate variability
Time frame: immediately after interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-optimal Health Status Questionnaire-25 (time frame: immediately after interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.