The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are: 1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application 2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application 3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL). 4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
Eligible subjects will receive active product to take daily for seven days
Eligible subjects will receive Placebo to take daily for seven days
San Francisco Research Institute
San Francisco, California, United States
Daily Diary - 24hr
To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary.
Time frame: from enrollment to the end of study at seven days
Mobile App - 24hr
To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application.
Time frame: from enrollment to the end of study at seven days
Daily Dairy - Days 1-6
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
Time frame: from enrollment to the end of study at seven days
Mobile App - Days 1-6
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
Time frame: from enrollment to the end of study at seven days
Green Climacteric Scale (GCS) - Days 1-6
To assess changes in stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
Time frame: from enrollment to the end of study at seven days
Menopause-Specific Quality of Life (MENQOL) - Days 1-6
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
Time frame: from enrollment to the end of study at seven days
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