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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan1 site
  • Yu- Cheng Kuo

    Taipei

Other trials in Taiwan

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 groups in NCT04845360
Study groupRoleWhat they receive
pregnancy and differences in gender can be found in the radial arterial pulseExperimentalEstablishing 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.

  1. 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.

  1. First posted15 Apr 2021
  2. Study start11 Nov 2019
  3. Primary completion10 Nov 2020
  4. Study completion10 Nov 2020

Resources

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)
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

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.

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