Harmonic WaveNCT04845360
Pulse Spectrum Analysis of Pregnant Women
A study testing pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan) in people with Harmonic Wave, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
ABSTRACT Background: Pulse diagnosis is a core clinical technique used in Chinese medicine to establish a patient's physiologic or pathologic status. Methods: We performed non--invasive recording of the radial arterial pulses for 36 pregnant women, and then compared the harmonics of the radial arterial pulse after… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Harmonic Wave
- What is being tested?
- pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Nov 2019to 10 Nov 2020
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant patients who visited the outpatient department (OPD)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: China Medical University, Taiwan
ABSTRACT Background: Pulse diagnosis is a core clinical technique used in Chinese medicine to establish a patient's physiologic or pathologic status.
Methods: We performed non--invasive recording of the radial arterial pulses for 36 pregnant women, and then compared the harmonics of the radial arterial pulse after Fourier transformation with those of 50 healthy nonpregnant women (controls).
Read the detailed description
The importance of information within arterial pulse waves has long been recognized in clinical medicine (Mohamed, 1872). Arterial pulse wave analysis has been employed widely in clinical practice, such as in cases of hypertension, cardiac failure, and ageing (O'Rourke, et al., 2001). Our previous studies revealed that the pulse spectrum of the radial arterial pulse could be highly correlated among patients with abnormal liver function (Wang, et al., 1996, Wang, et al., 1996). In addition, the specific Fourier components in the pulse provide more physiologic information than do systolic and diastolic blood pressure measurements during the process of dying (Kuo, et al., 2004, Kuo, et al., 2005). Recently, the fourth harmonic of the radial pulse wave has been shown to predict adverse cardiac events in asymptomatic patients with type 2 diabetes (Chang, et al., 2019)and pulse spectrum analysis has facilitated the diagnosis of coronary artery disease (Huang et al., 2019) One key method in Chinese medicine is using the harmonics of the arterial pulse to provide meridian information that can then be used to reveal a patient's physiologic and pathologic condition (Wang, et al., 2010).
In the clinic, the most dramatic physiologic event is pregnancy. Many documents discuss these issues in Chinese Medicine; for example, as stated in the bible of Chinese Medicine, Huang-Ti-Nei-Ching (1981),: "Normal pulse but appears weak, pregnancy" and "Significantly moving in Shaoyin (少陰) meridian, pregnancy." "Pulse Classics" (Wang, 2000) Another example is "Differential diagnosis of the Chi (尺), in which the pulse can detect the gender of the fetus, left larger than right is male; right larger than left is female." There is much information about pregnancy in pulse diagnosis, which has been practiced in clinics for a very long time. In fact, this practice has been used so long and so often that it has become difficult to determine the exact meaning and the accuracy of other practical approaches. Pulse diagnosis is the most important work to build the practicing definition of physiology, pathology, and diagnosis in the study of Chinese medicine.
In a previous study, we found that each organ and its related meridian are in resonance with a specific Fourier component of pressure wave (Wang, et al., 1994, Wang, et al., 1991). We also ascertained that the lower-frequency components were referred to as "Yin" and the higher ones as "Yang," and figured out the scientific meaning for the failure of hepatic, renal, or splenic Chi in the pulse (Kuo, et al., 2005). The meridian information gained through measuring the harmonics of blood pressure gives us qualitative and quantitative ways to realize the abstract statement in classic Chinese medicine. In the current study, we analyzed the blood pressure (BP) pulse of pregnant women to verify the information recorded with classic methods. We hypothesized that harmonics could be physiologic indicators corresponding with the gestation process. If we could find the relationship between harmonic information and pregnancy, we could confirm that the physiologic difference comes from the meridian, and could then precisely apply this information in the clinic.
- Conditions
- Harmonic Wave
- Being tested
- pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)
- Keywords
- Pulse diagnosis, Arterial pulse, Fourier transform, Gender differences, Pregnancy, Harmonics, Gestation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)Device
The device was fixed on the patient's skin with Scotch™ tape, along with an adjustable belt with a small button to give suitable pressure on the transducer.
| Study group | Role | What they receive |
|---|---|---|
| pregnancy and differences in gender can be found in the radial arterial pulse | Experimental | Establishing the meridian through harmonics of blood pressure waves could be a powerful tool to qualitatively and quantitatively indicate physiologic and pathologic factors. Receives: Device: pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meridian Differences in the Radial Pulse Wave in Pregnancy and with the Gender of the Fetus
Results showed in the right hand, the first and second harmonics were significantly higher among the pregnant group; in the left hand, the second (P < 0.01) and fourth (P < 0.05) harmonics were significantly higher among the pregnant group; 8 other harmonics were significantly lower among pregnant group (P <0.01). When we compared the synchronously recorded data from the right and left radial arterial pulses, significant differences by gender of the fetus was found for both hands. The first, second (P < 0.01), and third (P < 0.05) harmonic differences of the left and right radial arterial pulses were significantly higher when the fetus was male. The second harmonic was the most significant indicator of gender and monthly growth of the fetus.
Noninvasive pulse pressures of the right and left radical arteries were synchronously obtained at each OPD visit with a pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan).
Measured: two-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start11 Nov 2019
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Harmonic WaveStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We performed non--invasive recording of the radial arterial pulses for 36 pregnant women, and then compared the harmonics of the radial arterial pulse after Fourier transformation with those of 50 healthy nonpregnant women (controls).
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845360
- Sponsor's protocol ID
- /CMUH108-REC1-135
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 15 Apr 2021
- 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Medical University, Taiwan
- ClinicalTrials.gov ID
- NCT04845360
- Acronym / sponsor ID
- /CMUH108-REC1-135
- Conditions
- Harmonic Wave
- Keywords
- Pulse diagnosis, Arterial pulse, Fourier transform, Gender differences, Pregnancy, Harmonics, Gestation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 15 Apr 2021 (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.
ABSTRACT Background: Pulse diagnosis is a core clinical technique used in Chinese medicine to establish a patient's physiologic or pathologic status.
Methods: We performed non--invasive recording of the radial arterial pulses for 36 pregnant women, and then compared the harmonics of the radial arterial pulse after Fourier transformation with those of 50 healthy nonpregnant women (controls).
Detailed description
The importance of information within arterial pulse waves has long been recognized in clinical medicine (Mohamed, 1872). Arterial pulse wave analysis has been employed widely in clinical practice, such as in cases of hypertension, cardiac failure, and ageing (O'Rourke, et al., 2001). Our previous studies revealed that the pulse spectrum of the radial arterial pulse could be highly correlated among patients with abnormal liver function (Wang, et al., 1996, Wang, et al., 1996). In addition, the specific Fourier components in the pulse provide more physiologic information than do systolic and diastolic blood pressure measurements during the process of dying (Kuo, et al., 2004, Kuo, et al., 2005). Recently, the fourth harmonic of the radial pulse wave has been shown to predict adverse cardiac events in asymptomatic patients with type 2 diabetes (Chang, et al., 2019)and pulse spectrum analysis has facilitated the diagnosis of coronary artery disease (Huang et al., 2019) One key method in Chinese medicine is using the harmonics of the arterial pulse to provide meridian information that can then be used to reveal a patient's physiologic and pathologic condition (Wang, et al., 2010).
In the clinic, the most dramatic physiologic event is pregnancy. Many documents discuss these issues in Chinese Medicine; for example, as stated in the bible of Chinese Medicine, Huang-Ti-Nei-Ching (1981),: "Normal pulse but appears weak, pregnancy" and "Significantly moving in Shaoyin (少陰) meridian, pregnancy." "Pulse Classics" (Wang, 2000) Another example is "Differential diagnosis of the Chi (尺), in which the pulse can detect the gender of the fetus, left larger than right is male; right larger than left is female." There is much information about pregnancy in pulse diagnosis, which has been practiced in clinics for a very long time. In fact, this practice has been used so long and so often that it has become difficult to determine the exact meaning and the accuracy of other practical approaches. Pulse diagnosis is the most important work to build the practicing definition of physiology, pathology, and diagnosis in the study of Chinese medicine.
In a previous study, we found that each organ and its related meridian are in resonance with a specific Fourier component of pressure wave (Wang, et al., 1994, Wang, et al., 1991). We also ascertained that the lower-frequency components were referred to as "Yin" and the higher ones as "Yang," and figured out the scientific meaning for the failure of hepatic, renal, or splenic Chi in the pulse (Kuo, et al., 2005). The meridian information gained through measuring the harmonics of blood pressure gives us qualitative and quantitative ways to realize the abstract statement in classic Chinese medicine. In the current study, we analyzed the blood pressure (BP) pulse of pregnant women to verify the information recorded with classic methods. We hypothesized that harmonics could be physiologic indicators corresponding with the gestation process. If we could find the relationship between harmonic information and pregnancy, we could confirm that the physiologic difference comes from the meridian, and could then precisely apply this information in the clinic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We performed non--invasive recording of the radial arterial pulses for 36 pregnant women, and then compared the harmonics of the radial arterial pulse after Fourier transformation with those of 50 healthy nonpregnant women (controls).
| Arm | Type | Receives |
|---|---|---|
| pregnancy and differences in gender can be found in the radial arterial pulse | Experimental | Device: pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)Establishing the meridian through harmonics of blood pressure waves could be a powerful tool to qualitatively and quantitatively indicate physiologic and pathologic factors. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant patients who visited the outpatient department (OPD)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)The device was fixed on the patient's skin with Scotch™ tape, along with an adjustable belt with a small button to give suitable pressure on the transducer. | Device | pregnancy and differences in gender can be found in the radial arterial pulse |
Primary outcome
Meridian Differences in the Radial Pulse Wave in Pregnancy and with the Gender of the Fetus
Time frame: two-year study
Results showed in the right hand, the first and second harmonics were significantly higher among the pregnant group; in the left hand, the second (P < 0.01) and fourth (P < 0.05) harmonics were significantly higher among the pregnant group; 8 other harmonics were significantly lower among pregnant group (P <0.01). When we compared the synchronously recorded data from the right and left radial arterial pulses, significant differences by gender of the fetus was found for both hands. The first, second (P < 0.01), and third (P < 0.05) harmonic differences of the left and right radial arterial pulses were significantly higher when the fetus was male. The second harmonic was the most significant indicator of gender and monthly growth of the fetus. Noninvasive pulse pressures of the right and left radical arteries were synchronously obtained at each OPD visit with a pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan).
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 15 Apr 2021.
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?
A study testing pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan) in people with Harmonic Wave, run by China Medical University Hospital 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 1 inclusion and 1 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 15 Apr 2021. 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?
Meridian Differences in the Radial Pulse Wave in Pregnancy and with the Gender of the Fetus (time frame: two-year study). 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 15 Apr 2021.