MenstruationNCT04857736
A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery During Menstruation in Healthy Female College Students
An observational study of Menstruation and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 27 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation, Radial Artery
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 9 Mar 2022
- Phase
- Observational
- 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 18 to 27 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine.
Who may be able to join
- Trial group:
- Research period: March 9, 2021 to March 9, 2022;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine;
- Menstrual period in the same menstrual cycle: Days 2nd-4th of the menstrual cycle;
- Unmarried female college students aged 18-27 years old;
Show all 14Show fewer
- Female college students with informed consent to accept this pulse collection.
- Control group:
- Research period: March 9, 2021 to March 9, 2022;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine;
- Non-menstrual periods of the same menstrual cycle: Days 20th-28th of the menstrual cycle;
- Unmarried female college students aged 18-27 years old;
- Female college students with informed consent to accept this pulse collection.
Who cannot join
- Special menstruation: bimonthly menstruation, seasonal menstruation, annual menstruation and latent menstruation;
- Pregnant or lactating women;
- Ovulation period: generally on the 14th day before menstruation and three days before it and four days after it;
- Those with dysmenorrhea;
- Those with severe diseases;
- Patients with uterine or adjacent organ tissue diseases, including gynecological diseases, and diseases of waist, pelvis, colon and urinary system；
Show all 10Show fewer
- Those with infectious diseases;
- Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
- Incomplete information that affects the judgment of results due to subjective or objective reasons;
- Those with tremor of limbs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250014
Lili Cao, PH.D, qykyc309@163.com
Lucheng Song, PH.D
About this study
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 .
- Conditions
- Menstruation, Radial Artery
- Keywords
- Menstruation, Healthy Female College Students, Diagnostic Test, Radial Artery, sound waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The data will be collected, analyzed and calculated in about 7 days.
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.
Measured: The discovery of characteristic sound waves may take 3 months.
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.
Measured: Diagnostic tests may take about 1 month.
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.
Measured: 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start9 Apr 2021
- Primary completion9 Mar 2022 (estimated)
- Study completion9 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MenstruationStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lucheng Song, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857736
- Sponsor's protocol ID
- SFUYIN-02
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33350964Ullrich 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. doi: 10.1016/j.bbrc.2007.07.054. Epub 2007 Jul 23.
PubMed 17662243Lawlor 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. doi: 10.1093/eurheartj/ehi833. Epub 2006 Mar 21.
PubMed 16551651Kim 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.
PubMed 31273265Kim 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.
PubMed 21941587Minson 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. doi: 10.1161/01.cir.101.8.862.
PubMed 10694525Su 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.
PubMed 19480601Tada 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.
PubMed 28978872Maybin 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.
PubMed 26253932
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery During Menstruation in Healthy Female College Students
- ClinicalTrials.gov ID
- NCT04857736
- Acronym / sponsor ID
- SFUYIN-02
- Conditions
- Menstruation, Radial Artery
- Keywords
- Menstruation, Healthy Female College Students, Diagnostic Test, Radial Artery, sound waves
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 9 Mar 2022 (estimated)
- Study completion
- 9 Mar 2022 (estimated)
- First posted
- 23 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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". |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine.
Key inclusion criteria (14 listed)
- Research period: March 9, 2021 to March 9, 2022;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Healthy female college students with normal menstruation of Shandong University of Traditional Chinese Medicine;
- Menstrual period in the same menstrual cycle: Days 2nd-4th of the menstrual cycle;
- Unmarried female college students aged 18-27 years old;
Key exclusion criteria (10 listed)
- Special menstruation: bimonthly menstruation, seasonal menstruation, annual menstruation and latent menstruation;
- Pregnant or lactating women;
- Ovulation period: generally on the 14th day before menstruation and three days before it and four days after it;
- Those with dysmenorrhea;
- Those with severe diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 33350964Lee 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.
- Background: PubMed 17662243Ullrich 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. doi: 10.1016/j.bbrc.2007.07.054. Epub 2007 Jul 23.
- Background: PubMed 16551651Lawlor 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. doi: 10.1093/eurheartj/ehi833. Epub 2006 Mar 21.
- Background: PubMed 31273265Kim 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.
- Background: PubMed 21941587Kim 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.
- Background: PubMed 10694525Minson 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. doi: 10.1161/01.cir.101.8.862.
- Background: PubMed 19480601Su 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.
- Background: PubMed 28978872Tada 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.
- Background: PubMed 26253932Maybin 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.
Related trials for Menstruation
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Lucheng Song, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucheng Song, Doctor (+8613589089003, lucheng.s@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of abnormal sound waves in the pulses. (time frame: The data will be collected, analyzed and calculated in about 7 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857736, which also lists 9 linked publications.
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 23 Apr 2021.