PMSNCT06763809
A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
A study testing PMS Capsule and PMS Gummy in people with PMS and Menstrual Cramp, run by Semaine Health at 1 site in United States.
Trial summary
This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. 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
- PMS, Menstrual Cramp, Mood Change
- What is being tested?
- PMS Capsule and PMS Gummy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 12 Dec 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
- Female 18+ years of age.
- Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under 35.
- Must experience at least five of the following symptoms during their menstrual cycle:
- Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances
- Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week.
- If using hormonal contraception, must do so for at least three months before starting the trial, and remain consistent with taking it as per healthcare provider instructions during the study.
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- If using hormonal contraception, must allow for a bleed week every month.
- Must agree to avoid cannabis, CBD, ashwagandha, and supplements other than multivitamins or protein powders for 24 hours prior to the study, and during the full study duration.
- Willing to refrain from OTC pain medications or supplements to target period-related symptoms during the study period.
- Must live in the United States.
Who cannot join
- Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
- Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures.
- Anyone diagnosed with Graves disease, Hashimotos or taking any medication for their thyroid.
- Anyone who has undergone any surgeries or invasive treatments in the last six months, or is planning to during the study period.
- Anyone with any allergic reactions requiring the use of an Epi-pen.
- Anyone with known severe allergic reactions, or history of allergy or intolerance to ingredients found in over-the-counter dietary, vitamin or herbal supplements.
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- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Anyone with known allergies to nightshades (e.g., eggplant, tomato, bell pepper, potato).
- Unwilling to follow the study protocol.
- Anyone pregnant, breastfeeding, or trying to conceive currently or for the duration of the study.
- Participants will self-report that they are not pregnant.
- Current use of an extended activity hormonal contraception (examples include Depo-Provera injection, Nexplanon implant, or hormonal intrauterine devices (IUDs)).
- Currently participating in any other clinical study or planning to at any point during this study's duration.
- Anyone who has an alcohol dependency, regularly uses cannabis, or is using illicit drugs.
- Anyone with a history of substance abuse.
- Anyone who regularly takes supplements that might reduce inflammation or is planning to at any point during the study period.
- Anyone currently taking prescription pain medication for any indication.
- Anyone who is currently taking, or planning to take during the study period, any medications, supplements or products targeted at improving Premenstrual Syndrome symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.
- Conditions
- PMS, Menstrual Cramp, Mood Change
- Being tested
- PMS Capsule, Capsule Placebo, PMS Gummy, Gummy Placebo
- Keywords
- Fatigue, Bloating, Headaches/migraines, Constipation or diarrhea
- Medical subject headings
- Dysmenorrhea, Fatigue, Headache, Migraine Disorders, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMS CapsuleDietary supplement
Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
Capsule PlaceboDietary supplement
Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
PMS GummyDietary supplement
Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
Gummy PlaceboDietary supplement
Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
| Study group | Role | What they receive |
|---|---|---|
| PMS Capsule Group | Experimental | Participants in this arm will take the PMS capsule, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Boswellia, Milk Thistle Extract, Resveratrol, and Ashwagandha. Receives: Dietary Supplement: PMS Capsule |
| Capsule Placebo Group | Placebo comparator | Participants in this arm will take a placebo capsule, containing microcrystalline cellulose and other inert ingredients. Receives: Dietary Supplement: Capsule Placebo |
| PMS Gummy Group | Experimental | Participants in this arm will take the PMS gummy, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Lemon Balm Extract, Milk Thistle Extract, and Resveratrol. Receives: Dietary Supplement: PMS Gummy |
| Gummy Placebo Group | Placebo comparator | Participants in this arm will take a placebo gummy, containing inert ingredients such as tapioca syrup, cane sugar, and citric acid. Receives: Dietary Supplement: Gummy Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premenstrual Syndrome (PMS) Symptom Severity
Evaluate the effectiveness of the PMS capsule and gummy in alleviating symptoms associated with PMS, using the validated Menstrual Symptom Questionnaire (MSQ). The MSQ assesses 24 symptoms with scores ranging from 1 (never) to 5 (always), where a higher score indicates greater symptom severity.
Measured: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Secondary outcomes (1)
Participant Perception of PMS Symptom Relief
Assess participants' subjective perception of symptom relief provided by the PMS capsule and gummy, using a custom survey with questions related to satisfaction, effectiveness, and tolerability.
Measured: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start4 Sep 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PMSStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semaine Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763809
- Sponsor's protocol ID
- 20670
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06763809
- Acronym / sponsor ID
- 20670
- Conditions
- PMS, Menstrual Cramp, Mood Change
- Keywords
- Fatigue, Bloating, Headaches/migraines, Constipation or diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Semaine HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 8 Jan 2025 (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 virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PMS Capsule Group | Experimental | Dietary Supplement: PMS CapsuleParticipants in this arm will take the PMS capsule, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Boswellia, Milk Thistle Extract, Resveratrol, and Ashwagandha. |
| Capsule Placebo Group | Placebo comparator | Dietary Supplement: Capsule PlaceboParticipants in this arm will take a placebo capsule, containing microcrystalline cellulose and other inert ingredients. |
| PMS Gummy Group | Experimental | Dietary Supplement: PMS GummyParticipants in this arm will take the PMS gummy, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Lemon Balm Extract, Milk Thistle Extract, and Resveratrol. |
| Gummy Placebo Group | Placebo comparator | Dietary Supplement: Gummy PlaceboParticipants in this arm will take a placebo gummy, containing inert ingredients such as tapioca syrup, cane sugar, and citric acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female 18+ years of age.
- Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under 35.
- Must experience at least five of the following symptoms during their menstrual cycle:
- Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances
- Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week.
Key exclusion criteria (18 listed)
- Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
- Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures.
- Anyone diagnosed with Graves disease, Hashimotos or taking any medication for their thyroid.
- Anyone who has undergone any surgeries or invasive treatments in the last six months, or is planning to during the study period.
- Anyone with any allergic reactions requiring the use of an Epi-pen.
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 |
|---|---|---|
| PMS CapsuleParticipants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. | Dietary supplement | PMS Capsule Group |
| Capsule PlaceboParticipants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. | Dietary supplement | Capsule Placebo Group |
| PMS GummyParticipants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. | Dietary supplement | PMS Gummy Group |
| Gummy PlaceboParticipants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. | Dietary supplement | Gummy Placebo Group |
Primary outcome
Change in Premenstrual Syndrome (PMS) Symptom Severity
Time frame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Evaluate the effectiveness of the PMS capsule and gummy in alleviating symptoms associated with PMS, using the validated Menstrual Symptom Questionnaire (MSQ). The MSQ assesses 24 symptoms with scores ranging from 1 (never) to 5 (always), where a higher score indicates greater symptom severity.
1 secondary outcome
Participant Perception of PMS Symptom Relief
Time frame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
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 Jan 2025.
- 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 PMS Capsule and PMS Gummy in people with PMS and Menstrual Cramp, run by Semaine Health 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 10 inclusion and 18 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 Jan 2025. 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?
Change in Premenstrual Syndrome (PMS) Symptom Severity (time frame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)). 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 Jan 2025.