DysmenorrheaNCT03187782
Pulse Diagnoses in Patients While Dysmenorrhea is Attacking
An observational study of Dysmenorrhea, run by Taipei Hospital, Taiwan.
Trial summary
The mechanism led to the dysmenorrhea can be understood more clearly and one may have a better idea to treat the disease in the future. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- ANSWatch
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Feb 2015
- 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 12 to 55 years
- Women only
- Child, Adult
Study population: Fifteen patients suffering from dysmenorrhea who visited the traditional Chinese medicine outpatient department were recruited voluntarily in this study. All subjects live in the greater Taipei area.
Who may be able to join
- The inclusion criteria of the subjects were the presence of pain during menstruation or three days before it. It needed to recheck if the menstrual cycle appeared within three days after recruiting if dysmenorrhea attacked before menstruation.
Who cannot join
- The exclusion criterion was that subjects did not take pain killers in the 12 hours before measurement.
About this study
Official title: The Effect of Acupuncture Treatment of Acupoint San Yin Jiao on the Pulse Diagnoses in Patients While Dysmenorrhea is Attacking
The mechanism led to the dysmenorrhea can be understood more clearly and one may have a better idea to treat the disease in the future.
Read the detailed description
Background: Pulse diagnosis of the dysmenorrhea patients before and after acupuncture treatment on the acupoint San Yin Jiao (SP6) were performed so that the mechanism led to the pain can be understood more clearly and one may have a better idea to treat the disease in the future.
Methods: Fifteen women participated in the study voluntarily. They have first to fill in the form of Visual Analogue Scale (VAS) for pain. Then the pulse of the subjects were measured by ANSWatch before and after acupuncture. All meridians can be assessed by analyzing the pulse spectra through Fast Fourier Transform (FFT) of the original pulse data. The significant change of amplitude in certain harmonics which corresponds to a specific meridian after acupuncture treatment can be selected out.
- Conditions
- Dysmenorrhea
- Being tested
- ANSWatch
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANSWatchDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' radial artery pulses. Change is being assessed.
Get subjects' pulses by ANSWatch
Measured: Measure subjects' radial artery pulses before and after acupuncture in 10 minutes respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Kai Liao, Taipei Hospital, Taiwan
- Investigators
- Chen-Kai Liao, Principal investigator, Taipei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187782
- Sponsor's protocol ID
- TH-IRB-0014-0002
- Status last verified
- Jun 2017
- First submitted
- 25 May 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture Treatment of Acupoint San Yin Jiao on the Pulse Diagnoses in Patients While Dysmenorrhea is Attacking
- ClinicalTrials.gov ID
- NCT03187782
- Acronym / sponsor ID
- TH-IRB-0014-0002
- Conditions
- Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taipei Hospital, TaiwanUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Jun 2017 (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.
The mechanism led to the dysmenorrhea can be understood more clearly and one may have a better idea to treat the disease in the future.
Detailed description
Background: Pulse diagnosis of the dysmenorrhea patients before and after acupuncture treatment on the acupoint San Yin Jiao (SP6) were performed so that the mechanism led to the pain can be understood more clearly and one may have a better idea to treat the disease in the future.
Methods: Fifteen women participated in the study voluntarily. They have first to fill in the form of Visual Analogue Scale (VAS) for pain. Then the pulse of the subjects were measured by ANSWatch before and after acupuncture. All meridians can be assessed by analyzing the pulse spectra through Fast Fourier Transform (FFT) of the original pulse data. The significant change of amplitude in certain harmonics which corresponds to a specific meridian after acupuncture treatment can be selected out.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Fifteen patients suffering from dysmenorrhea who visited the traditional Chinese medicine outpatient department were recruited voluntarily in this study. All subjects live in the greater Taipei area.
Key inclusion criteria (1 listed)
- The inclusion criteria of the subjects were the presence of pain during menstruation or three days before it. It needed to recheck if the menstrual cycle appeared within three days after recruiting if dysmenorrhea attacked before menstruation.
Key exclusion criteria (1 listed)
- The exclusion criterion was that subjects did not take pain killers in the 12 hours before measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANSWatch | Diagnostic test | – |
Primary outcome
Patients' radial artery pulses. Change is being assessed.
Time frame: Measure subjects' radial artery pulses before and after acupuncture in 10 minutes respectively.
Get subjects' pulses by ANSWatch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Chen-Kai Liao principal investigator
Taipei Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhea, run by Taipei Hospital, 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patients' radial artery pulses. Change is being assessed. (time frame: Measure subjects' radial artery pulses before and after acupuncture in 10 minutes respectively.). 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 Jun 2017.