Clinical trial NCT04857736: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery During Menstruation in Healthy Female College Students
Official title: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery During Menstruation in Healthy Female College Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menstruation
Radial Artery
Keywords: Menstruation
Healthy Female College Students
Diagnostic Test
Radial Artery
sound waves
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine.

Brief summary: 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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Frequencies of abnormal sound waves in the pulses.
timeFrame: The data will be collected, analyzed and calculated in about 7 days.
measure: The Changes of sound waves in the pulses.
timeFrame: The discovery of characteristic sound waves may take 3 months.
measure: Diagnostic test
timeFrame: Diagnostic tests may take about 1 month.
measure: Sound waves analysis
timeFrame: 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Lucheng Song, Doctor
role: PRINCIPAL_INVESTIGATOR
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