Status Approved
First Submitted Date
2015/07/31
Registered Date
2015/08/27
Last Updated Date
2017/02/03
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001604 |
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Unique Protocol ID | PAS02-15D1-KH25 |
Public/Brief Title | Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period |
Scientific Title | Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KOMCIRB-150622-HR-021 |
Approval Date | 2015-06-30 |
Institutional Review Board Name | Kyung Hee University Korean Medicine Hospital Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Youngbae Park |
Title | Dr. |
Telephone | +82-2-958-9242 |
Affiliation | Kyung Hee University |
Address | College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul, Korea |
Contact Person for Public Queries | |
Name | Hyunho Kim |
Title | Dr. |
Telephone | +82-2-958-9242 |
Affiliation | Kyung Hee University |
Address | College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul, Korea |
Contact Person for Updating Information | |
Name | Jihye Kim |
Title | Miss |
Telephone | +82-42-868-9252 |
Affiliation | Korea Institute of Oriental Medicine |
Address | Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2015-08-10 Actual | |
Target Number of Participant | 48 | |
Primary Completion Date | 2016-02-28 , Actual | |
Study Completion Date | 2016-02-28 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyung Hee University Oriental Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2015-08-10 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
Project ID | K15023 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
7. Study Summary
Lay Summary | This is a protocol for an exploratory observational study that aims to assess the clinical efficacy of pulse tonometric device, and to determine whether the pulse tonometric device of diagnosis tools for primary dysmenorrhea can be used in clinic. This study will be conducted in a single center, case-controlled and exploratory observational study. A total of 48 participants will be enrolled in this study. The whole measurement process will be carried out in the Kyung Hee University Korean Medicine Hospital, Seoul, and Republic of Korea. Period of this study will be expected to be from June to November 2015. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Cross-sectional |
Target Number of Participant | 48 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label Control (healthy subjects) group |
Cohort/Group Description Group 2 consisting of 24 females with few premenstrual symptoms and Visual Analogue Scale (VAS) score< 4 were taken as controls. Compare and analyze pulse tonometric devices' parameters of dysmenorrhea patients group and control (healthy subjects) group. |
|
Cohort/ Group 2 |
Cohort/Group Label Dysmenorrhea patients group |
Cohort/Group Description Group 1 consisting of 24 females suffering from primary dysmenorrhea having Visual Analogue Scale (VAS) score ≥ 4. Compare and analyze pulse tonometric devices' parameters of dysmenorrhea patients group and control (healthy subjects) group. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | 24 women who have menstrual pain (dysmenorrhea) and 24 women who haven't menstrual pain which are residing in Seoul, Korea. |
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Sampling Method | Non-probablity sampling |
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N94.4)Primary dysmenorrhoea |
Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~30Year |
|
Description 1) Female aged 20 to 30 years 2) Women with a period cycle of 28 ± 3 days during last 3 months 3) Women who have menstrual pain (dysmenorrhea) over 4 degrees by Visual Analogue Scale (VAS) 4) Woman who can communicate with clinical study researcher and fill out a questionnaires 5) Woman who have a voluntary agreement and participation in this clinical study 6) Given written informed consent form. |
|
Exclusion Criteria |
1) Women with secondary dysmenorrhea caused by uterine myoma, endometriosis, ophorociptosis and infection of genitals confirmed by ultrasound exam 2) Women who have medical operations and procedures 3) who have major neuro-psychiatric disorder or have history of major neuro-psychiatric disorder, and women who are taking anti-depressant, anti-serotonin barbiturate, psychotropic drugs with 3 months 4) Women who have major medical disease or have history of major medical disease (hypertension, diabetes, hyperlipidemia, gastritis, enteritis, gastro-esophageal reflux disease, Crohn’s disease etc.) 5) Women who have an drastic diet within 1 week 6) Women who are pregnant, as determined by a urine pregnancy test 7) History of adverse reaction to pulse tonometric device 8) Women who have congenital vascular anomaly and experience fracture of the wrist 9) Received clinical study within one month prior to enrollment 10) Any other condition likely in the judgment of the investigator that make the participants unable to complete, or is unsuitable for the study. |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Pulse tonometric devices' parameter (pulse pressure index) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 1 | ||
Outcome | InBody 720s' parameters (intercellular water, extracellular water, protein, mineral, body fat mass, extracellular water/total body water ratio) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 2 | ||
Outcome | Total score of Measurement of Menstrual Pain (MMP) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 3 | ||
Outcome | Total score of Self-rating Anxiety Scale (SAS) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 4 | ||
Outcome | Toral score of Self-rating Depression Scale (SDS) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 5 | ||
Outcome | Total score of Cold and Heat Pattern Questionnaire (CHPQ) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 6 | ||
Outcome | Total score of Phlegm Pattern Questionnaire (PPQ) |
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Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 7 | ||
Outcome | Total score of Blood Stasis Pattern Questionnaire (BSPQ) |
|
Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 8 | ||
Outcome | Total score of Food Accumulation Pattern Questionnaire (FAPQ) |
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Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 9 | ||
Outcome | Total score of Seven Emotions Pattern Questionnaire (SEPQ) |
|
Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 10 | ||
Outcome | Total score of Fatigue Pattern Questionnaire (FPQ) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 11 | ||
Outcome | Pulse tonometric devices' parameter (pulse rate) |
|
Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 12 | ||
Outcome | Pulse tonometric devices' parameters (pulse depth index) |
|
Timepoint | After completion of the clinical study |
|
Secondary Outcome(s) 13 | ||
Outcome | Pulse tonometric devices' parameters (pulse volume index) |
|
Timepoint | After completion of the clinical study |
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Secondary Outcome(s) 14 | ||
Outcome | Tongue image |
|
Timepoint | After completion of the clinical study |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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