Midwestern University
Glendale, Arizona, 85308, United States
Completed
NCT Number: NCT06136104
The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.
Completed
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Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
All participants, after providing written informed consent, will drink a daily self-administered powder-mix supplement in water of either placebo or Mixhers HERTIME for 120 consecutive days. Surveys will be administered electronically to each participant in the first month to assess baseline menstrual cycle symptoms. In addition, before starting the supplement, participants will take the electronic survey "The Premenstrual Symptoms Screening Tool". During the first month of taking the supplement, participants will take an allergy and constitutional symptom survey electronically to assess for any adverse reactions to the product. Each month for four months, participants will complete an electronic survey assessing menstrual cycle symptoms after a menstrual cycle is completed.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Must be biologically female, must have a regular menstrual cycle (defined as a menstrual bleed every 23-35 days), must be a student, staff, or faculty member at Midwestern University Glendale, Arizona campus
Exclusion criteria
- not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia
Treatment and study plan
Mixhers HERTIME
Dietary SupplementA daily self-administered powder supplement packet mixed into water.
Placebo
Dietary SupplementA daily self-administered powder placebo supplement packet mixed into water.
Primary outcomes
-
Menstrual Cramping and/or Back Pain
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Mood Regulation
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 mood scale
-
Bloating
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Menstrual Bleeding Volume
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume
-
Menstrual Bleeding Duration
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding
Secondary outcomes
-
Fatigue
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced
-
Acne
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Difficulty Concentrating
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Overeating/Food Cravings
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Insomnia
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Hypersomnia
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
-
Period symptom interference with school/work efficiency/productivity
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey four-point Likert scale
-
Period symptom interference with social life activities
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey four-point Likert scale
-
Period symptom interference with physical activity (sports, gym, or daily performance)
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey four-point Likert scale
-
Any positive or negative mood changes noticed during period
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey free response prompt
-
Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey free response prompt
-
Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey free response prompt
-
Number of pads/tampons/other products used during menstrual bleeding
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey free response prompt
Other outcomes
-
Other miscellaneous changes noticed during menstrual bleeding
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey free response prompt
Sponsors and collaborators
Lead sponsor
Midwestern University
Other
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Nov 18, 2023
- Registry last updated
- May 8, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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