A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery During Menstruation in Healthy Female College Students

April 21, 2021 updated by: Lili Cao, Qianfoshan Hospital

Pulse diagnosis is an important method to judge the status of patients in the process of diagnosis and treatment of traditional Chinese medicine. At present, the commonly used site of pulse diagnosis is the radial artery, which is divided into "cun""guan" and "chi".During menstruation, the secretion of estrogen and progesterone drops to the lowest level. On the 7th day of menstruation in the proliferative period, the secretion of estrogen increases rapidly and rises to the first peak before ovulation. In the mid-secretory period, the secretion of estrogen rises to another peak, and the secretion of progesterone also reaches the highest peak. The state of the endometrium during non-menstrual period can be significantly different from the state of exfoliation and necrosis during menstruation. There are obvious differences in hormone levels and endometrial state and thickness in menstrual period and secretory period, especially in the middle and late secretion period, which affects the blood laminar flow of the uterine wall and is reflected in the acoustic information of the radial artery. Therefore, exploring the pulse manifestation of physiological menstruation can be expected to lay the foundation for assisting the diagnosis of pathological menstruation and endometrial diseases.

Our team found that there are low-frequency sound waves in the radial artery, which carry the physiological and pathological information of the organs in the body, and developed a "Pulse Detection System of Sound Waves ". Previous projects have explored the abnormal sound waves of radial artery in patients with sequelae of cerebral infarction, stable coronary heart disease, chronic gastritis, neck-shoulder syndrome, liver cirrhosis and other diseases and achieved certain results.

Therefore, in this study, the "Pulse Detection System of Sound Waves " will be used to collect the sound waves in the radial artery of 62 healthy female college students during menstruation and non-menstrual period within the same menstrual cycle , and researchers will carry on the frequency spectrum analysis and wavelet analysis to extract the pulse features. A diagnostic test was carried out by researchers to calculate the sensitivity and specificity of the "Sonic Pulse Detection System" in menstrual diagnosis. This study will verify the efficacy of pulse diagnosis of traditional Chinese medicine in the diagnosis of menstruation and lay a foundation for the diagnosis of pathological menstruation and endometrial diseases .

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Lucheng Song, PH.D
        • Sub-Investigator:
          • Wenjun Yu
        • Sub-Investigator:
          • Yameng Zhang, PH.D
        • Sub-Investigator:
          • Shanmei Sun, PH.D
        • Sub-Investigator:
          • Honglin Li
        • Principal Investigator:
          • Qian Wang
        • Sub-Investigator:
          • Mengqi Gao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 27 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine.

Description

Inclusion Criteria:

Trial group:

  1. Research period: March 9, 2021 to March 9, 2022;
  2. Research site: The First Affiliated Hospital of Shandong First Medical University;
  3. Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine;
  4. Menstrual period in the same menstrual cycle: Days 2nd-4th of the menstrual cycle;
  5. Unmarried female college students aged 18-27 years old;
  6. Female college students with informed consent to accept this pulse collection.

Control group:

  1. Research period: March 9, 2021 to March 9, 2022;
  2. Research site: The First Affiliated Hospital of Shandong First Medical University;
  3. Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine;
  4. Non-menstrual periods of the same menstrual cycle: Days 20th-28th of the menstrual cycle;
  5. Unmarried female college students aged 18-27 years old;
  6. Female college students with informed consent to accept this pulse collection.

Exclusion Criteria:

  1. Special menstruation: bimonthly menstruation, seasonal menstruation, annual menstruation and latent menstruation;
  2. Pregnant or lactating women;
  3. Ovulation period: generally on the 14th day before menstruation and three days before it and four days after it;
  4. Those with dysmenorrhea;
  5. Those with severe diseases;
  6. Patients with uterine or adjacent organ tissue diseases, including gynecological diseases, and diseases of waist, pelvis, colon and urinary system；
  7. Those with infectious diseases;
  8. Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
  9. Incomplete information that affects the judgment of results due to subjective or objective reasons;
  10. Those with tremor of limbs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Trial group: 62 healthy female college students during menstruation
The pulse sound waves of three parts and five layers of each of the two hands of 62 healthy female college students during menstruation will be collected by the"Pulse Detection System of Sound Waves".
Control group :62 healthy female college students during non-menstrual period
The pulse sound waves of three parts and five layers of each of the two hands of 62 healthy female college students during non-menstrual period will be collected by the "Pulse Detection System of Sound Waves".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sound waves analysis
Time Frame: 1 month.

The Hertz (Hz) of the different segments of the sound waves in Wavelet transform.

The Hertz (Hz) of the different layers of the sound waves in Hilbert-Huang. The SMPL amplitudes of the sound waves in Discrete Fourier Transform. The sampEn of sound waves in Sample Entropy.
1 month.
Frequencies of abnormal sound waves in the pulses.
Time Frame: The data will be collected, analyzed and calculated in about 7 days.
Using Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands. The percentage% of Frequencies of abnormal sound waves in the pulse will be calculated.
The data will be collected, analyzed and calculated in about 7 days.
The Changes of sound waves in the pulses.
Time Frame: The discovery of characteristic sound waves may take 3 months.
The Changes of sound waves at different Hertz(Hz) frequencies and SMPL(Units of cool edit amplitude) amplitudes will be compared between menstrual period and non-menstrual period of healthy female college students.
The discovery of characteristic sound waves may take 3 months.
Diagnostic test
Time Frame: Diagnostic tests may take about 1 month.
The percentage(%) of specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of the menstrual period of healthy female college students.
Diagnostic tests may take about 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Lucheng Song, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Anticipated)

March 9, 2022

Study Completion (Anticipated)

March 9, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SFUYIN-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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