Suboptimal Health StatusNCT05522413
Pulse Momentum Research in Pulse Diagnosis
An observational study of Suboptimal Health Status, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Suboptimal Health Status
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2022to 10 Jul 2023
- 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: Participants have no chronic disease or those who have been diagnosed as Sub-optimal health status by a doctor.
Who may be able to join
- A+B+C or A+B+D that meet the following description, and those who have no clear diagnosis of chronic diseases by western medicine, can be included:
- Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24~29 Kg/m2
Who cannot join
- Considerations for selection/exclusion criteria include:
- Those with a clear diagnosis of chronic diseases in Western medicine, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease, etc., which fall within the scope of chronic diseases under the National Health Insurance
- Have a definite diagnosis of mental illness by Western medicine
- Cancer patients
- Pregnancy
- Those with obvious inflammatory infection at the time of receipt of the case
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Yen-Ying KUNG, doctor
About this study
Official title: Quantitative Research on Pulse Momentum in Pulse Diagnosis of Traditional Chinese Medicine
Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. However, the finger feeling is difficult to be expressed in a quantitative approach for clinical teaching and illness-state recognition. The pressure sensor was applied to measure wrist pulse waveforms for analysis. In this research project, the "discrete wavelet transformation (DWT)" is used to decompose the time-domain pulse into several sets of signals, which are allocated at different frequency bands. The high-frequency signal over the range of 12-50 Hz is then acquired to calculate the spectral energy ratio (SER) for quantization of the pulse momentum to the persons under the suboptimal health status (SHS).
Read the detailed description
Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. Ancient physicians classified the pulse types on the basis of pulse manifestation attributes and finger-feeling features. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. However, the finger feeling is difficult to be expressed in a quantitative approach for clinical teaching and illness-state recognition. The modernization of pulse diagnosis in Taiwan began in the 1970s. The pressure sensor was applied to measure wrist pulse waveforms for analysis. Nowadays, the pulse "position", "number", and "shape" have been quantitatively analyzed and classified by using time-domain pulse signals and their corresponding frequency spectrums. However, since it is lack of effective high-frequency pulse acquisition method and quantitative approach, the quantitative research on "pulse momentum" for judgement of pathological status is still being investigated.
In this research project, the "discrete wavelet transformation (DWT)" is used to decompose the time-domain pulse into several sets of signals, which are allocated at different frequency bands. The high-frequency signal over the range of 12-50 Hz is then acquired to calculate the spectral energy ratio (SER) for quantization of the pulse momentum. In addition, the approximate entropy (ApEn) of the high-frequency signal is computed and defined as a new quantitative factor of pulse momentum. It will be further tried to relate the scores of clinical questionnaires. The analysis method proposed in this project has been preliminarily applied to analyze the pulse waveforms of the persons under the suboptimal health status (SHS) to demonstrate the effectiveness. In the future, more measured pulses of the subject under test will be collected and analyzed to examine the robustness of the proposed method. It is also planned to figure out the relationship between the quantitative factors, such as SER and ApEn, and the high- and low-frequency parameters of the heart rate variability (HRV). It can be further linked to the activation of sympathetic and parasympathetic nerves, and potentially build up an objective bridge of clinical diagnosis to connect the traditional Chinese medicine and modern western medicine.
- Conditions
- Suboptimal Health Status
- Keywords
- discrete wavelet transformation, Pulse diagnosis in TCM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health Status | normal examination in recent six months and not fit inclusion criteria of suboptimal health status. | |
| Suboptimal health Status | (A) Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24~29 Kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse diagnosis data analysis
Palpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument are read into the processing program, and then the time domain signal of each pulse position is analyzed in sequence .
Measured: 1 day
Secondary outcomes (1)
Suboptimal health status questionnaires
25 items of Suboptimal symptoms
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start10 Aug 2022
- Primary completion10 Jul 2023 (estimated)
- Study completion10 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suboptimal Health StatusStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- Yen-Ying KUNG, doctor, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522413
- Sponsor's protocol ID
- 2022-06-014AC
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Research on Pulse Momentum in Pulse Diagnosis of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05522413
- Acronym / sponsor ID
- 2022-06-014AC
- Conditions
- Suboptimal Health Status
- Keywords
- discrete wavelet transformation, Pulse diagnosis in TCM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Jul 2023 (estimated)
- Study completion
- 10 Jul 2023 (estimated)
- First posted
- 31 Aug 2022 (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.
Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. However, the finger feeling is difficult to be expressed in a quantitative approach for clinical teaching and illness-state recognition. The pressure sensor was applied to measure wrist pulse waveforms for analysis. In this research project, the "discrete wavelet transformation (DWT)" is used to decompose the time-domain pulse into several sets of signals, which are allocated at different frequency bands. The high-frequency signal over the range of 12-50 Hz is then acquired to calculate the spectral energy ratio (SER) for quantization of the pulse momentum to the persons under the suboptimal health status (SHS).
Detailed description
Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. Ancient physicians classified the pulse types on the basis of pulse manifestation attributes and finger-feeling features. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. However, the finger feeling is difficult to be expressed in a quantitative approach for clinical teaching and illness-state recognition. The modernization of pulse diagnosis in Taiwan began in the 1970s. The pressure sensor was applied to measure wrist pulse waveforms for analysis. Nowadays, the pulse "position", "number", and "shape" have been quantitatively analyzed and classified by using time-domain pulse signals and their corresponding frequency spectrums. However, since it is lack of effective high-frequency pulse acquisition method and quantitative approach, the quantitative research on "pulse momentum" for judgement of pathological status is still being investigated.
In this research project, the "discrete wavelet transformation (DWT)" is used to decompose the time-domain pulse into several sets of signals, which are allocated at different frequency bands. The high-frequency signal over the range of 12-50 Hz is then acquired to calculate the spectral energy ratio (SER) for quantization of the pulse momentum. In addition, the approximate entropy (ApEn) of the high-frequency signal is computed and defined as a new quantitative factor of pulse momentum. It will be further tried to relate the scores of clinical questionnaires. The analysis method proposed in this project has been preliminarily applied to analyze the pulse waveforms of the persons under the suboptimal health status (SHS) to demonstrate the effectiveness. In the future, more measured pulses of the subject under test will be collected and analyzed to examine the robustness of the proposed method. It is also planned to figure out the relationship between the quantitative factors, such as SER and ApEn, and the high- and low-frequency parameters of the heart rate variability (HRV). It can be further linked to the activation of sympathetic and parasympathetic nerves, and potentially build up an objective bridge of clinical diagnosis to connect the traditional Chinese medicine and modern western medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Status | – | –normal examination in recent six months and not fit inclusion criteria of suboptimal health status. |
| Suboptimal health Status | – | –(A) Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24~29 Kg/m2 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants have no chronic disease or those who have been diagnosed as Sub-optimal health status by a doctor.
Key inclusion criteria (2 listed)
- A+B+C or A+B+D that meet the following description, and those who have no clear diagnosis of chronic diseases by western medicine, can be included:
- Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24~29 Kg/m2
Key exclusion criteria (6 listed)
- Considerations for selection/exclusion criteria include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse diagnosis data analysis
Time frame: 1 day
Palpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument are read into the processing program, and then the time domain signal of each pulse position is analyzed in sequence .
1 secondary outcome
Suboptimal health status questionnaires
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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.
Yen-Ying KUNG, doctor study director
Taipei Veterans General Hospital, Taiwan
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 Suboptimal Health Status, run by Taipei Veterans General Hospital, Taiwan 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Ying KUNG, doctor (886-2-28757453 ext. 333, yykung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse diagnosis data analysis (time frame: 1 day). 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 31 Aug 2022.