The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Healthy Clinical Trial

Official title:

The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06136104
• Other study ID #: 23007
• Status: Completed
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: November 2023
• Source: Midwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Premenstrual Dysphoric Disorder
• Premenstrual Syndrome

Intervention

Dietary Supplement:
• Mixhers HERTIME
A daily self-administered powder supplement packet mixed into water.
• Placebo
A daily self-administered powder placebo supplement packet mixed into water.

Locations

Country	Name	City	State
United States	Midwestern University	Glendale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other miscellaneous changes noticed during menstrual bleeding	Measured through post-menstrual bleeding electronic survey free response prompt	120 days
Primary	Menstrual Cramping and/or Back Pain	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Primary	Mood Regulation	Measured through post-menstrual bleeding electronic survey 1-10 mood scale	120 days
Primary	Bloating	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Primary	Menstrual Bleeding Volume	Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume	120 days
Primary	Menstrual Bleeding Duration	Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding	120 days
Secondary	Fatigue	Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced	120 days
Secondary	Acne	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Secondary	Difficulty Concentrating	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Secondary	Overeating/Food Cravings	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Secondary	Insomnia	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Secondary	Hypersomnia	Measured through post-menstrual bleeding electronic survey 1-10 severity scale	120 days
Secondary	Period symptom interference with school/work efficiency/productivity	Measured through post-menstrual bleeding electronic survey four-point Likert scale	120 days
Secondary	Period symptom interference with social life activities	Measured through post-menstrual bleeding electronic survey four-point Likert scale	120 days
Secondary	Period symptom interference with physical activity (sports, gym, or daily performance)	Measured through post-menstrual bleeding electronic survey four-point Likert scale	120 days
Secondary	Any positive or negative mood changes noticed during period	Measured through post-menstrual bleeding electronic survey free response prompt	120 days
Secondary	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
Secondary	Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding	Measured through post-menstrual bleeding electronic survey free response prompt	120 days
Secondary	Number of pads/tampons/other products used during menstrual bleeding	Measured through post-menstrual bleeding electronic survey free response prompt	120 days