Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period

Not Applicable

Completed

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0001604
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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.

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse tonometric devices' parameter (pulse pressure index)

Secondary Outcome Measures

Name	Time	Method
InBody 720s' parameters (intercellular water, extracellular water, protein, mineral, body fat mass, extracellular water/total body water ratio);Total score of Measurement of Menstrual Pain (MMP);Total score of Self-rating Anxiety Scale (SAS);Toral score of Self-rating Depression Scale (SDS);Total score of Cold and Heat Pattern Questionnaire (CHPQ);Total score of Phlegm Pattern Questionnaire (PPQ);Total score of Blood Stasis Pattern Questionnaire (BSPQ);Total score of Food Accumulation Pattern Questionnaire (FAPQ);Total score of Seven Emotions Pattern Questionnaire (SEPQ);Total score of Fatigue Pattern Questionnaire (FPQ);Pulse tonometric devices' parameter (pulse rate);Pulse tonometric devices' parameters (pulse depth index);Pulse tonometric devices' parameters (pulse volume index);Tongue image