HealthyNCT06136104
The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
A study testing Mixhers HERTIME in people with Healthy and Premenstrual Dysphoric Disorder, run by Midwestern University at 1 site in United States.
Trial summary
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Premenstrual Dysphoric Disorder, Premenstrual Syndrome
- What is being tested?
- Mixhers HERTIME
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.
Read the 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.
- Being tested
- Mixhers HERTIME, Placebo
- Keywords
- PMS (Premenstrual syndrome), PMDD (Premenstrual dysphoric disorder), Period Symptoms, Menstrual Cycle, Menstrual Cramping, Menstrual Bleeding
- Medical subject headings
- Premenstrual Dysphoric Disorder, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixhers HERTIMEDietary supplement
A daily self-administered powder supplement packet mixed into water.
PlaceboDietary supplement
A daily self-administered powder placebo supplement packet mixed into water.
| Study group | Role | What they receive |
|---|---|---|
| Mixhers HERTIME | Experimental | 1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water Receives: Dietary Supplement: Mixhers HERTIME |
| Placebo | Placebo comparator | 1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Cramping and/or Back Pain
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Mood Regulation
Measured through post-menstrual bleeding electronic survey 1-10 mood scale
Measured: 120 days
Bloating
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Menstrual Bleeding Volume
Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume
Measured: 120 days
Menstrual Bleeding Duration
Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding
Measured: 120 days
Secondary outcomes (13)
Fatigue
Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced
Measured: 120 days
Acne
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Difficulty Concentrating
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Overeating/Food Cravings
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Insomnia
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Hypersomnia
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Measured: 120 days
Period symptom interference with school/work efficiency/productivity
Measured through post-menstrual bleeding electronic survey four-point Likert scale
Measured: 120 days
Period symptom interference with social life activities
Measured through post-menstrual bleeding electronic survey four-point Likert scale
Measured: 120 days
Period symptom interference with physical activity (sports, gym, or daily performance)
Measured through post-menstrual bleeding electronic survey four-point Likert scale
Measured: 120 days
Any positive or negative mood changes noticed during period
Measured through post-menstrual bleeding electronic survey free response prompt
Measured: 120 days
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
Measured: 120 days
Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding
Measured through post-menstrual bleeding electronic survey free response prompt
Measured: 120 days
Number of pads/tampons/other products used during menstrual bleeding
Measured through post-menstrual bleeding electronic survey free response prompt
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Aug 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farshad Agahi, MD, Principal investigator, Midwestern University- Glendale, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136104
- Sponsor's protocol ID
- 23007
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
- ClinicalTrials.gov ID
- NCT06136104
- Acronym / sponsor ID
- 23007
- Keywords
- PMS (Premenstrual syndrome), PMDD (Premenstrual dysphoric disorder), Period Symptoms, Menstrual Cycle, Menstrual Cramping, Menstrual Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixhers HERTIME | Experimental | Dietary Supplement: Mixhers HERTIME1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixhers HERTIMEA daily self-administered powder supplement packet mixed into water. | Dietary supplement | Mixhers HERTIME |
| PlaceboA daily self-administered powder placebo supplement packet mixed into water. | Dietary supplement | Placebo |
Primary outcome
Menstrual Cramping and/or Back Pain
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Mood Regulation
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 mood scale
Bloating
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Menstrual Bleeding Volume
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume
Menstrual Bleeding Duration
Time frame: 120 days
Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding
13 secondary outcomes
Fatigue
Time frame: 120 days
Acne
Time frame: 120 days
Difficulty Concentrating
Time frame: 120 days
Overeating/Food Cravings
Time frame: 120 days
Insomnia
Time frame: 120 days
Hypersomnia
Time frame: 120 days
Period symptom interference with school/work efficiency/productivity
Time frame: 120 days
Period symptom interference with social life activities
Time frame: 120 days
Period symptom interference with physical activity (sports, gym, or daily performance)
Time frame: 120 days
Any positive or negative mood changes noticed during period
Time frame: 120 days
Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding
Time frame: 120 days
Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding
Time frame: 120 days
Number of pads/tampons/other products used during menstrual bleeding
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farshad Agahi, MD principal investigator
Midwestern University- Glendale, AZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixhers HERTIME in people with Healthy and Premenstrual Dysphoric Disorder, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Cramping and/or Back Pain (time frame: 120 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.