An interventional study of Ginger formula and Placebo in Painful Menstruation, sponsored by Givaudan France Naturals. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Givaudan France Naturals · Not applicable, Interventional, and Other
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.
402 studies on the registry are indexed under Dysmenorrhea; 94 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 336 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Givaudan France Naturals is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Dietary Supplement: Ginger formula
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.
Dietary Supplement: Placebo
supplement delivering a minimum of 20 mg of gingeroids / d
Matching capsule (identical color and size) containing arabic gum and flavouring
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).
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.
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).
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.
Participants will report the total number of hours they experienced menstrual pain over the past 24 hours. Numeric entry : 0-24h.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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."
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.
Participants complete a purpose-built questionnaire covering 4 domains: overall product satisfaction, perceived benefit, recommendation likelihood, and blinding perception.
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.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 187 interventional studies with no phase under Dysmenorrhea, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 10 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Givaudan France Naturals