Women's HealthNCT06535698
Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.
A study testing Perelel Health Hormonal Balance Support in people with Women's Health, run by Perelel Inc. at 1 site in United States.
Trial summary
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Perelel Health Hormonal Balance Support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 10 Jun 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid new hormonal balance treatments during the study
- Consistent use of current hormonal balance treatments for at least 3 months prior to the study
Who cannot join
- Chronic conditions preventing adherence to the protocol Diabetes
- Planned hormonal balance-related procedures during the study
- Started any new medications or supplements that target hormonal balance in the past 3 months
- Anyone with diabetes
- Severe allergies requiring EpiPen
- Pregnant, breastfeeding, or trying to conceive
- Recent surgeries or planned surgeries during the study
- Unwilling to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.
- Conditions
- Women's Health
- Being tested
- Perelel Health Hormonal Balance Support
- Keywords
- Hormonal Balance Support, Menstrual Cycle, Mood Swings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perelel Health Hormonal Balance SupportDietary supplement
The supplement contains Myo-inositol (1000 mcg), Metabolic balance blend (200 mcg) including Berberine HCl, Alpha lipoic acid, DIM (33'-Diindolylmethane), and D-chiro-inositol (25 mg). Other ingredients include Vegetable cellulose (capsule), plant cellulose, and L-leucine.
| Study group | Role | What they receive |
|---|---|---|
| Hormonal Balance Support Supplement | Experimental | Participants in this arm will receive Perelel Health hormonal balance support capsules. The dosage regimen is as follows:
Week 1: 1 capsule daily in the evening Week 2: 2 capsules daily in the evening Weeks 3-12: 4 capsules daily (2 in the morning and 2 in the evening) The supplement contains Myo-inositol (1000 mcg), Metabolic balance blend (200 mcg) including Berberine HCl, Alpha lipoic acid, DIM (33'-Diindolylmethane), and D-chiro-inositol (25 mg). Other ingredients include Vegetable cellulose (capsule), plant cellulose, and L-leucine. Receives: Dietary Supplement: Perelel Health Hormonal Balance Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Symptoms of Hormonal Imbalance
Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (1)
Changes in Overall Menstrual Health
Assessment of the impact of Perelel Health hormonal balance support on menstrual health using a self-reported questionnaire.
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start19 Feb 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perelel Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535698
- Sponsor's protocol ID
- 20403
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.
- ClinicalTrials.gov ID
- NCT06535698
- Acronym / sponsor ID
- 20403
- Conditions
- Women's Health
- Keywords
- Hormonal Balance Support, Menstrual Cycle, Mood Swings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Perelel Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 2 Aug 2024 (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.
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormonal Balance Support Supplement | Experimental | Dietary Supplement: Perelel Health Hormonal Balance SupportParticipants in this arm will receive Perelel Health hormonal balance support capsules. The dosage regimen is as follows: Week 1: 1 capsule daily in the evening Week 2: 2 capsules daily in the evening Weeks 3-12: 4 capsules daily (2 in the morning and 2 in the evening) The supplement contains Myo-inositol (1000 mcg), Metabolic balance blend (200 mcg) including Berberine HCl, Alpha lipoic acid, DIM (33'-Diindolylmethane), and D-chiro-inositol (25 mg). Other ingredients include Vegetable cellulose (capsule), plant cellulose, and L-leucine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid new hormonal balance treatments during the study
- Consistent use of current hormonal balance treatments for at least 3 months prior to the study
Key exclusion criteria (8 listed)
- Chronic conditions preventing adherence to the protocol Diabetes
- Planned hormonal balance-related procedures during the study
- Started any new medications or supplements that target hormonal balance in the past 3 months
- Anyone with diabetes
- Severe allergies requiring EpiPen
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 |
|---|---|---|
| Perelel Health Hormonal Balance SupportThe supplement contains Myo-inositol (1000 mcg), Metabolic balance blend (200 mcg) including Berberine HCl, Alpha lipoic acid, DIM (33'-Diindolylmethane), and D-chiro-inositol (25 mg). Other ingredients include Vegetable cellulose (capsule), plant cellulose, and L-leucine. | Dietary supplement | Hormonal Balance Support Supplement |
Primary outcome
Changes in Symptoms of Hormonal Imbalance
Time frame: Baseline, Week 4, Week 8, Week 12
Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.
1 secondary outcome
Changes in Overall Menstrual Health
Time frame: Baseline, Week 4, Week 8, Week 12
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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perelel Health Hormonal Balance Support in people with Women's Health, run by Perelel Inc. 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 4 inclusion and 8 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 2 Aug 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. 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?
Changes in Symptoms of Hormonal Imbalance (time frame: Baseline, Week 4, Week 8, Week 12). 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 2 Aug 2024.