The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Not Applicable

Completed

• Conditions: Premenstrual Syndrome; Healthy; Premenstrual Dysphoric Disorder
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Mixhers HERTIME

• Registration Number: NCT06136104
• Lead Sponsor: Midwestern University

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.

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2023-10-27
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water
Mixhers HERTIME	Mixhers HERTIME	1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water

Primary Outcome Measures

Name	Time	Method
Bloating	120 days	Measured through post-menstrual bleeding electronic survey 1-10 severity scale
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
Menstrual Bleeding Volume	120 days	Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume
Menstrual Bleeding Duration	120 days	Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding

Secondary Outcome Measures

Name	Time	Method
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
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
Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding	120 days	Measured through post-menstrual bleeding electronic survey free response prompt
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
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
Insomnia	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
Period symptom interference with physical activity (sports, gym, or daily performance)	120 days	Measured through post-menstrual bleeding electronic survey four-point Likert scale
Number of pads/tampons/other products used during menstrual bleeding	120 days	Measured through post-menstrual bleeding electronic survey free response prompt

Trial Locations

Locations (1)

Midwestern University; 🇺🇸 Glendale, Arizona, United States