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Clinical Trials/JPRN-UMIN000053169
JPRN-UMIN000053169
Not yet recruiting
未知

A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation - A study of the effects of consumption of the test beverage on improvement of unidentified complaints associated with menstruation

everage Brain Inc.0 sites60 target enrollmentDecember 22, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Healthy adult female
Sponsor
everage Brain Inc.
Enrollment
60
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 22, 2023
End Date
October 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
everage Brain Inc.

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\)Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system 2\)Subject who is under medication on a steady basis or history of medication for serious disorders 3\)Subject currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy) 4\)Subject with gynecological disorders (secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, uterine body cancer, ovarian cancer, etc.) 5\)Subject who has difficulty drinking study beverage 6\)Subject who takes medications and supplements on a daily basis \*Except subject who can cancel an intake of health foods and supplements during this trial 7\)Subject who has no menstrual discomfort symptoms at all, do not use over\-the\-counter pain relievers at all when symptoms are present, or whose symptoms are severe and cannot be controlled with over\-the\-counter pain relievers. 8\)Subject who is pregnant, lactating mother, or who is willing to become pregnant during this trial 9\)Any candidates considered to be ineligible for enrollment due to the results of health condition questionnaire 10\)Subject who took part in the other clinical/monitoring trial within a month before giving informed consent to take part in this trial. 11\)Subject with area IV on the Neuroticism Discriminant Chart of the CMI Health Questionnaire 12\)Those whose total score on the Postmenstrual Associated Symptom Questionnaire is 0 points or higher than the total score on the Premenstrual Associated Symptom Questionnaire or the total score on the Menstrual Associated Symptom Questionnaire during menstruation, regarding the Menstrual Associated Symptoms Questionnaire (pre\-survey). 13\)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator

Outcomes

Primary Outcomes

Not specified

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