A study of the effectiveness of the milk component for menstrual symptoms

Not Applicable

• Conditions: Healthy people

• Registration Number: JPRN-UMIN000037316
• Lead Sponsor: everage Brain Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Study Completion: 2020-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Pregnant, lactating women or willing to be pregnancy during the study 2) Subjects who are willing to become pregnant during this study 3) Subjects who have histories of gynecologic disorder or have gynecologic disorder * Gynecologic disorder: Secondary amenorrhea, Dysmenorrhea, Endometriosis, Fibroid, Premenstrual dysphoric disorder (PMDD , Breast cancer, Cervical cancer, Uterine body cancer, Ovary cancer etc. 4) Subject with allergy to milk, wheat, egg, shrimp, crab, or subjects with lactose intolerance 5) Subjects who had participated in other clinical trials or monitoring studies within 2 month prior to obtaining informed consent 6) Subjects without menstruation pain, or subjects with severe menstruation pain and unable to control the pain by taking over-the-counter analgesic medication 7) Subjects classified as psychosomatic (Type IV) by CMI health questionnaire 8) Subjects with a score of 20 and above for the stress score by Brief Stress Level Check List 9) Subjects whose total score of menstrual symptoms survey items at the point of postmenstrual period is 1 or more points higher compared to the total score of the survey items before a menstrual period begins or during menstrual period in menstrual symptoms survey items (preliminary survey) 10) Subject who is ineligible for this study due to medical doctor's judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score of menstrual symptoms survey items

Secondary Outcome Measures

Name	Time	Method
- Physical symptom score of menstrual symptoms survey items - Psychological symptoms score of menstrual symptoms survey items - VAS for menstrual pain