The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Aug 2023
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedMay 8, 2024
November 1, 2023
4 months
October 27, 2023
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (13)
Fatigue
120 days
Acne
120 days
Difficulty Concentrating
120 days
Overeating/Food Cravings
120 days
Insomnia
120 days
- +8 more secondary outcomes
Other Outcomes (1)
Other miscellaneous changes noticed during menstrual bleeding
120 days
Study Arms (2)
Mixhers HERTIME
EXPERIMENTAL1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water
Placebo
PLACEBO COMPARATOR1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water
Interventions
A daily self-administered powder supplement packet mixed into water.
A daily self-administered powder placebo supplement packet mixed into water.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Midwestern University
Glendale, Arizona, 85308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farshad Agahi, MD
Midwestern University- Glendale, AZ
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 18, 2023
Study Start
August 30, 2023
Primary Completion
December 20, 2023
Study Completion
December 20, 2023
Last Updated
May 8, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share