Clinical trial NCT06136104: The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
Official title: The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Keywords: PMS (Premenstrual syndrome)
PMDD (Premenstrual dysphoric disorder)
Period Symptoms
Menstrual Cycle
Menstrual Cramping
Menstrual Bleeding
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Menstrual Cramping and/or Back Pain
timeFrame: 120 days
measure: Mood Regulation
timeFrame: 120 days
measure: Bloating
timeFrame: 120 days
measure: Menstrual Bleeding Volume
timeFrame: 120 days
measure: Menstrual Bleeding Duration
timeFrame: 120 days
Secondary outcomes:
measure: Fatigue
timeFrame: 120 days
measure: Acne
timeFrame: 120 days
measure: Difficulty Concentrating
timeFrame: 120 days
measure: Overeating/Food Cravings
timeFrame: 120 days
measure: Insomnia
timeFrame: 120 days
measure: Hypersomnia
timeFrame: 120 days
measure: Period symptom interference with school/work efficiency/productivity
timeFrame: 120 days
measure: Period symptom interference with social life activities
timeFrame: 120 days
measure: Period symptom interference with physical activity (sports, gym, or daily performance)
timeFrame: 120 days
measure: Any positive or negative mood changes noticed during period
timeFrame: 120 days
measure: Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding
timeFrame: 120 days
measure: Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding
timeFrame: 120 days
measure: Number of pads/tampons/other products used during menstrual bleeding
timeFrame: 120 days
Other outcomes:
measure: Other miscellaneous changes noticed during menstrual bleeding
timeFrame: 120 days
Locations:
city: Glendale
country: United States
facility: Midwestern University
state: Arizona
Study officials:
affiliation: Midwestern University- Glendale, AZ
name: Farshad Agahi, MD
role: PRINCIPAL_INVESTIGATOR
References: