The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
88
Eligible subjects will receive Placebo to take daily for five weeks
Eligible subjects will receive active product to take daily for five weeks
See Final Report
San Francisco, California, United States
Changes of symptom scores in Daily Dairy
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Time frame: from enrollment to the end of study at five weeks
Changes of symptom scores in Mobile Application
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Time frame: from enrollment to the end of study at five weeks
Changes in Menopause-Specific Quality of Life (MENQOL) Scores
To assess changes in mood and quality of life scores of the product compared to placebo
Time frame: from enrollment to the end of study at five weeks
Changes in Green Climacteric Scale (GCS) Scores
To assess changes in mood scores of the product compared to placebo
Time frame: from enrollment to the end of study at five weeks
Changes in Perceived Stress Scale (PSS) Scores
To assess changes in mood scores of the product compared to placebo
Time frame: from enrollment to the end of study at five weeks
Changes in Profile of Mood States (POMS) Scores
To assess changes in mood scores of the product compared to placebo
Time frame: from enrollment to the end of study at five weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
To assess changes in sleep scores of the product compared to placebo
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Time frame: from enrollment to the end of study at five weeks