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

Menstruation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857736
• Other study ID #: SFUYIN-02
• Status: Recruiting
• Start date: April 9, 2021
• Est. completion date: March 9, 2022

Study information

• Verified date: April 2021
• Source: Qianfoshan Hospital
• Contact: Lucheng Song, Doctor
• Phone: +8613589089003
• Email: lucheng.s[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstruation
• Radial Artery

Locations

Country	Name	City	State
China	Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Kim J, Bae JH, Ku B, Yim MH, Ang L, Kim H, Jeon YJ. A comparative study of the radial pulse between primary dysmenorrhea patients and healthy subjects during the menstrual phase. Sci Rep. 2019 Jul 4;9(1):9716. doi: 10.1038/s41598-019-46066-2. — View Citation

Kim JU, Jeon YJ, Kim YM, Lee HJ, Kim JY. Novel diagnostic model for the deficient and excess pulse qualities. Evid Based Complement Alternat Med. 2012;2012:563958. doi: 10.1155/2012/563958. Epub 2011 Sep 5. — View Citation

Lawlor DA, Timpson N, Ebrahim S, Day IN, Smith GD. The association of oestrogen receptor alpha-haplotypes with cardiovascular risk factors in the British Women's Heart and Health Study. Eur Heart J. 2006 Jul;27(13):1597-604. Epub 2006 Mar 21. — View Citation

Lee JHS, Cheng EOL, Choi KM, Ngu SF, Cheung RYK; Hong Kong College of Obstetricians and Gynaecologists. 2020 Hong Kong College of Obstetricians and Gynaecologists guideline on investigations of premenopausal women with abnormal uterine bleeding. Hong Kong Med J. 2020 Dec;26(6):520-525. doi: 10.12809/hkmj208897. — View Citation

Maybin JA, Critchley HO. Menstrual physiology: implications for endometrial pathology and beyond. Hum Reprod Update. 2015 Nov-Dec;21(6):748-61. doi: 10.1093/humupd/dmv038. Epub 2015 Aug 7. Review. — View Citation

Minson CT, Halliwill JR, Young TM, Joyner MJ. Influence of the menstrual cycle on sympathetic activity, baroreflex sensitivity, and vascular transduction in young women. Circulation. 2000 Feb 29;101(8):862-8. — View Citation

Su SY, Wei CC, Hsieh CL, Tsao JY, Li TC, Lin TH, Chang HH, Lo LC. Influence of menstrual cycle on pulse pressure waveforms measured from the radial artery in biphasic healthy women. J Altern Complement Med. 2009 Jun;15(6):645-52. doi: 10.1089/acm.2008.0022. — View Citation

Tada Y, Yoshizaki T, Tomata Y, Yokoyama Y, Sunami A, Hida A, Kawano Y. The Impact of Menstrual Cycle Phases on Cardiac Autonomic Nervous System Activity: An Observational Study Considering Lifestyle (Diet, Physical Activity, and Sleep) among Female College Students. J Nutr Sci Vitaminol (Tokyo). 2017;63(4):249-255. doi: 10.3177/jnsv.63.249. — View Citation

Ullrich ND, Koschak A, MacLeod KT. Oestrogen directly inhibits the cardiovascular L-type Ca2+ channel Cav1.2. Biochem Biophys Res Commun. 2007 Sep 21;361(2):522-7. Epub 2007 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of abnormal sound waves in the pulses.	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.
Primary	The Changes of sound waves in the pulses.	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.
Primary	Diagnostic test	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.
Primary	Sound waves analysis	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.