Healthy, Premenstrual Dysphoric Disorder, Premenstrual Syndrome
Conditions
Keywords
PMS (Premenstrual syndrome), PMDD (Premenstrual dysphoric disorder), Period Symptoms, Menstrual Cycle, Menstrual Cramping, Menstrual Bleeding
Brief summary
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMixhers HERTIME
A daily self-administered powder supplement packet mixed into water.
DIETARY_SUPPLEMENTPlacebo
A daily self-administered powder placebo supplement packet mixed into water.
Sponsors
Midwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Bleeding Duration | 120 days | Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding |
| Menstrual Cramping and/or Back Pain | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Mood Regulation | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 mood scale |
| Bloating | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Menstrual Bleeding Volume | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Hypersomnia | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Period symptom interference with school/work efficiency/productivity | 120 days | Measured through post-menstrual bleeding electronic survey four-point Likert scale |
| Period symptom interference with social life activities | 120 days | Measured through post-menstrual bleeding electronic survey four-point Likert scale |
| Any positive or negative mood changes noticed during period | 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 | 120 days | Measured through post-menstrual bleeding electronic survey free response prompt |
| Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding | 120 days | Measured through post-menstrual bleeding electronic survey free response prompt |
| Number of pads/tampons/other products used during menstrual bleeding | 120 days | Measured through post-menstrual bleeding electronic survey free response prompt |
| Period symptom interference with physical activity (sports, gym, or daily performance) | 120 days | Measured through post-menstrual bleeding electronic survey four-point Likert scale |
| Fatigue | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced |
| Acne | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Difficulty Concentrating | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
| Overeating/Food Cravings | 120 days | Measured through post-menstrual bleeding electronic survey 1-10 severity scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other miscellaneous changes noticed during menstrual bleeding | 120 days | Measured through post-menstrual bleeding electronic survey free response prompt |
Countries
United States
Outcome results
None listed