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.

Study Overview

• Status: Completed
• Conditions: Healthy; Premenstrual Dysphoric Disorder; Premenstrual Syndrome
• Intervention / Treatment: Dietary supplement: Mixhers HERTIME; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Midwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other miscellaneous changes noticed during menstrual bleeding	Measured through post-menstrual bleeding electronic survey free response prompt	120 days

Collaborators and Investigators

• Sponsor: Midwestern University
• Investigators: Principal Investigator: Farshad Agahi, MD, Midwestern University- Glendale, AZ

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Menstrual Cycle; Menstrual Bleeding; PMS (Premenstrual syndrome); PMDD (Premenstrual dysphoric disorder); Period Symptoms; Menstrual Cramping
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Dysphoric Disorder; Premenstrual Syndrome
• Other Study ID Numbers: 23007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No