The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

NCT ID: NCT06136104

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2023-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Premenstrual Dysphoric Disorder Premenstrual Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mixhers HERTIME

1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water

Group Type EXPERIMENTAL

Mixhers HERTIME

Intervention Type DIETARY_SUPPLEMENT

A daily self-administered powder supplement packet mixed into water.

Placebo

1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A daily self-administered powder placebo supplement packet mixed into water.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mixhers HERTIME

A daily self-administered powder supplement packet mixed into water.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A daily self-administered powder placebo supplement packet mixed into water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Midwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Farshad Agahi, MD

Role: PRINCIPAL_INVESTIGATOR

Midwestern University- Glendale, AZ

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Midwestern University

Glendale, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Estrogen, HDL, and Coronary Heart Disease in Women
NCT00083824 COMPLETED PHASE2/PHASE3
Acupuncture for Relieving Perimenopausal Symptoms
NCT01933204 COMPLETED PHASE2/PHASE3