The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.

Detailed Description
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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.

Official Title
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The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Conditions
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Healthy, Premenstrual Dysphoric Disorder, Premenstrual Syndrome

Intervention / Treatment
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* Dietary Supplement: Mixhers HERTIME
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mixhers HERTIME<br>1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water | Dietary Supplement: Mixhers HERTIME<br>* A daily self-administered powder supplement packet mixed into water.<br>|
| Placebo Comparator: Placebo<br>1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water | Dietary Supplement: Placebo<br>* A daily self-administered powder placebo supplement packet mixed into water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual Cramping and/or Back Pain | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Mood Regulation | Measured through post-menstrual bleeding electronic survey 1-10 mood scale | 120 days | 
| Bloating | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Menstrual Bleeding Volume | Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume | 120 days | 
| Menstrual Bleeding Duration | Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced | 120 days | 
| Acne | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Difficulty Concentrating | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Overeating/Food Cravings | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Insomnia | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Hypersomnia | Measured through post-menstrual bleeding electronic survey 1-10 severity scale | 120 days | 
| Period symptom interference with school/work efficiency/productivity | Measured through post-menstrual bleeding electronic survey four-point Likert scale | 120 days | 
| Period symptom interference with social life activities | Measured through post-menstrual bleeding electronic survey four-point Likert scale | 120 days | 
| Period symptom interference with physical activity (sports, gym, or daily performance) | Measured through post-menstrual bleeding electronic survey four-point Likert scale | 120 days | 
| Any positive or negative mood changes noticed during period | Measured through post-menstrual bleeding electronic survey free response prompt | 120 days | 
| Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding | Measured through post-menstrual bleeding electronic survey free response prompt | 120 days | 
| Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding | Measured through post-menstrual bleeding electronic survey free response prompt | 120 days | 
| Number of pads/tampons/other products used during menstrual bleeding | Measured through post-menstrual bleeding electronic survey free response prompt | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMS (Premenstrual syndrome), PMDD (Premenstrual dysphoric disorder), Period Symptoms, Menstrual Cycle, Menstrual Cramping, Menstrual Bleeding