- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05522413
Pulse Momentum Research in Pulse Diagnosis
Quantitative Research on Pulse Momentum in Pulse Diagnosis of Traditional Chinese Medicine
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yen-Ying KUNG, doctor
- Phone Number: 333 886-2-28757453
- Email: yykung@vghtpe.gov.tw
Study Contact Backup
- Name: Chao-Hsiung Tseng, doctor
- Phone Number: 886-2-27376416
- Email: chtseng@mail.ntust.edu.tw
Study Locations
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Taipei, Taiwan, 112
- Recruiting
- Taipei Veterans General Hospital
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Contact:
- Yen-Ying KUNG, doctor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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:
(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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Health Status
normal examination in recent six months and not fit inclusion criteria of suboptimal health status.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pulse diagnosis data analysis
Time Frame: 1 day
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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 .
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suboptimal health status questionnaires
Time Frame: 1 day
|
25 items of Suboptimal symptoms
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1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Yen-Ying KUNG, doctor, Taipei Veterans General Hospital, Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-06-014AC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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