Painful MenstruationGinFlowNCT07894406
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
A study testing Ginger formula in people with Painful Menstruation, run by Givaudan France Naturals.
Trial summary
This study will test whether a standardized ginger extract improves menstrual pain and related symptoms compared with placebo in women with painful periods. Participants aged 18 to 40 will be randomly assigned to ginger extract or placebo, then complete one menstrual cycle without study product to establish baseline. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Painful Menstruation
- What is being tested?
- Ginger formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female individuals aged ≥18 and ≤40 years at time of screening.
- Regular menstrual cycle between 21 and 35 days
- Menstrual period of 3 to 7 days
- With primary dysmenorrhea defined as a visual analog score (VAS) for pain of ≥4 in the 3 previous months (reported) and at cycle 0 (measured)
- BMI is ≥ 18.5 and < 30 kg/m2
- Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Females not of child-bearing potential (i.e., surgically sterile or post-menopausal ≥12 months) are exempt from this criterion.
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- Willing to complete online surveys at scheduled time points.
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.
- Provides voluntary, written, informed consent to participate in the study prior to any study procedures.
- Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.
- Has an appropriate wearable device (Garmin, Oura, Whoop, Apple Watch, Samsung Watch, Google Health devices) and is willing to share data.
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Underlying diseases, e.g., endometriosis, fibroids (myomas) and pelvic tumor, adenomyosis, endometrial polyps, and pelvic inflammatory disease, and finally, any kind of gynecologic surgery (laparotomy or laparoscopic surgery of cysts, tumors, and intra pelvic adhesions)
- Irregular menstrual cycle defined as cycle length <21 or >35 days, metrorrhagia, or oligomenorrhea
- Anyone who has started, changed, or stopped taking hormonal birth control in the last three months and has a planned insertion or replacement of an IUD in the next 3 months
- Regular use of NSAIDs (defined as use ≥3 days/week for ≥3 months) for indications other than dysmenorrhea (e.g., chronic inflammatory or rheumatologic conditions), where discontinuation for the study duration is contraindicated per investigator judgment
- Unwilling to agree to rescue medication requirements as described in the protocol (see concomitant meds section)
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- Any significant change in physical activity level (≥1 day/week or ≥30 min/week of vigorous activity) in the 3 months prior to enrollment, or unwillingness to maintain stable physical activity for the study duration
- History of cancer, psychological, neurological, hematological, or other clinically significant systemic disorders
- History of kidney or liver disease, non-gynecological abdominal or pelvic surgery (e.g., bowel, bladder, appendix, or urological procedures) that could affect or be confused with menstrual pain.
- Use of blood thinner, antidiabetic, antiarrhythmic or blood pressure medications.
- Using a dietary supplement which could significantly affect parameters followed during the study according to the investigator (i.e ginger (any supplemental form), chasteberry, evening primrose oil, black cohosh, chamomile and any supplement marketed for menstrual health, PMS, or period pain relief) or stopped less than 6 weeks before inclusion or not willing to refrain their consumption during the study
- Consumption of food and/or drink and/or condiment containing ginger (gari, pickled ginger, Japanese food, tea or infusion…) defined as more than 4 times per week prior to the study
- Do not agree to limit ginger consumption to maximally 4 times a week during the study
- Known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient
- Ongoing abuse of drugs and/or alcohol and/or medications at the time of enrolment and history of substance abuse within the last 12 months before enrolment
- Drinking more than 2 glasses of alcohol per day, every day and without interruption, and not willing to keep their drinking habits unchanged throughout the study
- Smoker more than 10 cigarettes per day
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements
- Currently enrolled in any other clinical trial
- Unable to give informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Manon Lecomte, PhD contact
About this study
Official title: The Effect of a Ginger Formulation on Menstrual Health: a Randomized Double-blind Placebo-controlled Trial
This study will test whether a standardized ginger extract improves menstrual pain and related symptoms compared with placebo in women with painful periods. Participants aged 18 to 40 will be randomly assigned to ginger extract or placebo, then complete one menstrual cycle without study product to establish baseline. They will then take 2 capsules daily for two menstrual cycles. Neither participants nor the study team will know who receives which product. The study is conducted entirely remotely. Researchers will measure menstrual pain intensity and duration, rescue medication use, menstrual and premenstrual symptoms, and the impact of symptoms on daily life.
- Conditions
- Painful Menstruation
- Being tested
- Ginger formula, Placebo
- Keywords
- Menstrual pain, Menstrual Symptoms, Premenstrual Symptoms, Ginger, Women's Health, Dietary supplement
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger formulaDietary supplement
supplement delivering a minimum of 20 mg of gingeroids / d
PlaceboDietary supplement
Matching capsule (identical color and size) containing arabic gum and flavouring
| Study group | Role | What they receive |
|---|---|---|
| Ginger formula | Experimental | 100 mg of ginger formula per capsule, 2 capsules per day from the first day of menstruation in Cycle 1 through the last day of menstruation in Cycle 2. Receives: Dietary Supplement: Ginger formula |
| Placebo formula | Placebo comparator | Matching capsule in size and colour, containing gum arabic and flavouring, 2 capsules per day, from the first day of menstruation in Cycle 1 through the last day of menstruation in Cycle 2. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menstrual pain intensity VAS from Cycle 0 to Cycle 2.
Mean daily Visual Analogue Scale (VAS) pain intensity across menstrual days 1-3, Change from Cycle 0 to Cycle 2. VAS consists of a 100 mm line anchored by "no pain" (0 cm) and "pain as bad as it could be" (10 cm); scores reported in cm (0-10).
Measured: Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 2. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Secondary outcomes (13)
Change in menstrual pain intensity VAS from Cycle 0 to Cycle 1.
Mean daily Visual Analogue Scale (VAS) pain intensity across menstrual days 1-3, Change from Cycle 0 to Cycle 1. VAS consists of a 100 mm line anchored by "no pain" (0 cm) and "pain as bad as it could be" (10 cm); scores reported in cm (0-10).
Measured: Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 1 (3 days after first dose). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual pain duration (hours) from Cycle 0 to Cycle 1 and Cycle 2.
Participants will report the total number of hours they experienced menstrual pain over the past 24 hours. Numeric entry : 0-24h.
Measured: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual rescue medicine use from Cycle 0 to Cycle 1 and Cycle 2.
Participants will report whether they used acetaminophen over the past 24 hours. If yes, participants will report the dose (500 mg or 1000 mg) and the number of doses taken during the past 24 hours (1-4 doses).
Measured: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual bleeding flow from Cycle 0 to Cycle 1 and Cycle 2.
Menstrual flow over the past 24 hours will be assessed using a single categorical item, with response options of light, moderate, heavy, or my period has ended.
Measured: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in the Verbal Multidimensional Scoring system (VMS) from Cycle 0 to Cycle 1 and Cycle 2.
VMS provides categorical assessment of menstrual pain severity across four grades (0-3): Painless menstruation =0, menstruation with pain but rare use of analgesics or limitation of activities =1, menstruation with moderate pain with influence on daily activities and use of analgesics with relief =2, and menstruation with severe pain with significant limitations on daily activities, ineffective use of analgesics, and such symptoms as headache, tenderness, nausea, vomiting, and diarrhea =3. Participants select the grade description that best matches their experience during the entire past menstruation phase.
Measured: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual gastrointestinal symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2.
Individual gastrointestinal symptoms, including bloating, nausea, and transit disturbances (diarrhea/constipation), will be evaluated using a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible). Scores will be analyzed on a per-item basis.
Measured: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual physical symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2.
Individual physical symptoms, including headache, fatigue, and muscle/bone/joint pain, will be evaluated using a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible). Scores will be analyzed on a per-item basis.
Measured: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2.
Quality of life impact will be evaluated through 3 individual items assessing the degree to which symptoms interfere with work/school participation, relationships, and enjoyment of life, using a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always). Individual item scores will be analyzed separately.
Measured: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual physical symptom NRS from Cycle 0 to Cycle 1 and Cycle 2.
Physical symptom severity during the premenstrual phase will be assessed through 5 individual items evaluating bloating, nausea, breast tenderness, headaches, and muscle/bone/joint pain. Responses will be recorded on a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible severity). Scores will be analyzed on a per-item basis.
Measured: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual psychological symptom NRS from Cycle 0 to Cycle 1 and Cycle 2.
Psychological symptom severity during the premenstrual phase will be assessed through 8 individual items evaluating mood swings, anger/irritability, sadness/low mood, anxiety/tension, feeling overwhelmed/unable to cope, difficulty concentrating, fatigue/low energy, and changes in appetite (overeating/food cravings). Responses will be recorded on a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible severity). Scores will be analyzed on a per-item basis.
Measured: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2.
Quality of life impact will be evaluated through 3 individual items assessing the degree to which symptoms interfere with work/school participation, relationships, and enjoyment of life, using a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always). Individual item scores will be analyzed separately.
Measured: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Patient global impression of change (PGIC).
The Patient Global Impression of Change (PGIC) is a single-item measure on which participants rate their overall change in menstrual symptoms since the start of the study on a 7-point scale ranging from "very much worse" to "very much improved."
Measured: Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Participant's Consumer Experience.
Participants complete a purpose-built questionnaire covering 4 domains: overall product satisfaction, perceived benefit, recommendation likelihood, and blinding perception.
Measured: Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful MenstruationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group trial with one untreated baseline cycle (Cycle 0) followed by two treatment cycles (Cycles 1 and 2).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Barbara A Davis, PhD, RD, Principal investigator, Ingredient Factor, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894406
- Sponsor's protocol ID
- GIV001
- Acronym
- GinFlow
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant-level data supporting the published results will be available upon reasonable request to qualified researchers following publication and subject to a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ginger Formulation on Menstrual Health: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07894406
- Acronym / sponsor ID
- GinFlow / GIV001
- Conditions
- Painful Menstruation
- Keywords
- Menstrual pain, Menstrual Symptoms, Premenstrual Symptoms, Ginger, Women's Health, Dietary supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Oct 2026 (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 study will test whether a standardized ginger extract improves menstrual pain and related symptoms compared with placebo in women with painful periods. Participants aged 18 to 40 will be randomly assigned to ginger extract or placebo, then complete one menstrual cycle without study product to establish baseline. They will then take 2 capsules daily for two menstrual cycles. Neither participants nor the study team will know who receives which product. The study is conducted entirely remotely. Researchers will measure menstrual pain intensity and duration, rescue medication use, menstrual and premenstrual symptoms, and the impact of symptoms on daily life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group trial with one untreated baseline cycle (Cycle 0) followed by two treatment cycles (Cycles 1 and 2).
| Arm | Type | Receives |
|---|---|---|
| Ginger formula | Experimental | Dietary Supplement: Ginger formula100 mg of ginger formula per capsule, 2 capsules per day from the first day of menstruation in Cycle 1 through the last day of menstruation in Cycle 2. |
| Placebo formula | Placebo comparator | Dietary Supplement: PlaceboMatching capsule in size and colour, containing gum arabic and flavouring, 2 capsules per day, from the first day of menstruation in Cycle 1 through the last day of menstruation in Cycle 2. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy female individuals aged ≥18 and ≤40 years at time of screening.
- Regular menstrual cycle between 21 and 35 days
- Menstrual period of 3 to 7 days
- With primary dysmenorrhea defined as a visual analog score (VAS) for pain of ≥4 in the 3 previous months (reported) and at cycle 0 (measured)
- BMI is ≥ 18.5 and < 30 kg/m2
Key exclusion criteria (20 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Underlying diseases, e.g., endometriosis, fibroids (myomas) and pelvic tumor, adenomyosis, endometrial polyps, and pelvic inflammatory disease, and finally, any kind of gynecologic surgery (laparotomy or laparoscopic surgery of cysts, tumors, and intra pelvic adhesions)
- Irregular menstrual cycle defined as cycle length <21 or >35 days, metrorrhagia, or oligomenorrhea
- Anyone who has started, changed, or stopped taking hormonal birth control in the last three months and has a planned insertion or replacement of an IUD in the next 3 months
- Regular use of NSAIDs (defined as use ≥3 days/week for ≥3 months) for indications other than dysmenorrhea (e.g., chronic inflammatory or rheumatologic conditions), where discontinuation for the study duration is contraindicated per investigator judgment
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 |
|---|---|---|
| Ginger formulasupplement delivering a minimum of 20 mg of gingeroids / d | Dietary supplement | Ginger formula |
| PlaceboMatching capsule (identical color and size) containing arabic gum and flavouring | Dietary supplement | Placebo formula |
Primary outcome
Change in menstrual pain intensity VAS from Cycle 0 to Cycle 2.
Time frame: Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 2. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Mean daily Visual Analogue Scale (VAS) pain intensity across menstrual days 1-3, Change from Cycle 0 to Cycle 2. VAS consists of a 100 mm line anchored by "no pain" (0 cm) and "pain as bad as it could be" (10 cm); scores reported in cm (0-10).
13 secondary outcomes
Change in menstrual pain intensity VAS from Cycle 0 to Cycle 1.
Time frame: Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 1 (3 days after first dose). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual pain duration (hours) from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual rescue medicine use from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual bleeding flow from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in the Verbal Multidimensional Scoring system (VMS) from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual gastrointestinal symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual physical symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in menstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual physical symptom NRS from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual psychological symptom NRS from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Change in premenstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2.
Time frame: Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Patient global impression of change (PGIC).
Time frame: Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Participant's Consumer Experience.
Time frame: Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. De-identified participant-level data supporting the published results will be available upon reasonable request to qualified researchers following publication and subject to a data sharing agreement.
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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.
Manon Lecomte, PhD contact
Barbara A Davis, PhD, RD principal investigator
Ingredient Factor, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Ginger formula in people with Painful Menstruation, run by Givaudan France Naturals.
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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alethios (650-334-8239, support@alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menstrual pain intensity VAS from Cycle 0 to Cycle 2. (time frame: Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 2. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively.). 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 26 Oct 2026.