The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Sponsor

Midwestern University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06136104

Collaborator

(none)

100

Enrollment

Location

Arms

4.1

Anticipated Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Premenstrual Dysphoric Disorder Premenstrual Syndrome	Dietary Supplement: Mixhers HERTIME Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Actual Study Start Date :

Aug 30, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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
Menstrual Bleeding Duration [120 days]
Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding

Secondary Outcome Measures

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
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
Period symptom interference with physical activity (sports, gym, or daily performance) [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

Other Outcome Measures

Other miscellaneous changes noticed during menstrual bleeding [120 days]
Measured through post-menstrual bleeding electronic survey free response prompt

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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