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Study of the effect of intake of test supplement on urinary voiding in women: A randomized, double blind, and parallel group comparison study

Not Applicable
Conditions
Healthy adult
Registration Number
JPRN-UMIN000046982
Lead Sponsor
EP Mediate Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
82
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who are judged to have overactive bladder (2) Subjects who have nocturia more than twice in the bladder diary before start of intake of trial supplement (3) Subjects who are undergoing hospitalization/treatment for dysuria, or those who have been judged to require treatments (4) Subjects who are unable to measure or record the urine volume for a designated period (5) Subjects who have urinary tract infection, urinary tract stones, kidney stones, ureteral stones, gallstones, etc. (6) Subjects who are taking health foods, etc. that affect urination at least once a week, or those who wish to take them during the study period (7) Subjects who are currently taking medication or exercise therapy (8) Subjects who have or history diseases such as diabetes, hepatic, renal, or cardiac diseases, or diseases that affect the secretion of adrenal cortical hormones, or other metabolic diseases (9) Subjects who have a disease that requires constant medication, those who have a disease under treatment , those who have a history of serious disease that required medication, and those who are scheduled for surgery. (10) Subjects who may develop allergies in relation to the research. (11) Subjects who have participated in other clinical trials within the past month prior to the pre-test date. (12) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study (13) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range (14) Subjects who are judged to be unsuitable as subjects based on the background survey. (15) Subjects who plan to become pregnant or breastfeed during the study period (16) Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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