A study to verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women

A study to verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women: a randomized, placebo-controlled, double-blind, crossover comparison study - A study to verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061811

Enrollment

Registered

2026-06-05

Start date

2026-06-05

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

&lt

Duration&gt

One menstrual cycle (two times) &lt

Test product&gt

Test 1: Test food (food containing inositol) Test 2: Placebo (food not containing inositol) &lt

Administration&gt

Chew and take two tablets per day after the first meal of the day. *If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and shoul

Test1: Placebo (food not containing inositol) Test2: Test food (food containing inositol) &lt

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Women 3. Individuals aged between 20 and 39 4. Healthy individuals 5. Individuals who have common menstrual complaints 6. Individuals whose past three menstrual cycle have been between 25 and 38 days 7. Individuals whose lasting period of the menstruation is between three and seven days

Exclusion criteria

Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are undergoing medical treatment or have a medical history of gynecological disease {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial cancer, or ovarian cancer} 5. Individuals who have severe menstrual pain that cannot be controlled with analgesics 6. Individuals who are undergoing medical treatment or have a medical history of psychiatric disorder 7. Individuals who receive hormonal therapy 8. Individuals who are currently taking low dosage pill (oral contraceptive) 9. Postmenopausal individuals 10. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 11. Individuals who are taking or using medications (including herbal medicines) or supplements 12. Individuals who are allergic to medications and foods related to the test product, particularly those allergic to rice 13. Individuals who are pregnant, lactating, or planning pregnancy during this study 14. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
1. The measured value of score of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the examination after consumption	—

Secondary

Measure	Time frame
1. The change and percentage change in score of Neg Affect in the MDQ (before menstruation) from screening (Scr) 2. The measured values of score of Neg Affect (during and after menstruation), Pain (before, during and after menstruation),Water Reten (before, during and after menstruation),Auto React (before, during and after menstruation),Impair Conc (before, during and after menstruation),Behave Change (before, during and after menstruation),Arousal (before, during and after menstruation),and Control (before, during and after menstruation) and their changes and percentage changes from Scr 3. Individuals whose responses to each item the MDQ improved by at least one grade at Test 1 (after consumption) and Test 2 (after consumption) compared with Test 1 (before consumption) and Test 2 (before consumption) 4. Individuals whose responses to "get irritated by trivial things," "feel anxious," "get sleepy during the day," "low concentration," "strong appetite," and "feel malaise" improved by at least one grade at Test 1 (after consumption) and Test 2 (after consumption) compared with Test 1 (before consumption) and Test 2 (before consumption) 5. Individuals who experienced adverse events	—

Measure

Time frame

1. The change and percentage change in score of Neg Affect in the MDQ (before menstruation) from screening (Scr) 2. The measured values of score of Neg Affect (during and after menstruation), Pain (before, during and after menstruation),Water Reten (before, during and after menstruation),Auto React (before, during and after menstruation),Impair Conc (before, during and after menstruation),Behave Change (before, during and after menstruation),Arousal (before, during and after menstruation),and Control (before, during and after menstruation) and their changes and percentage changes from Scr 3. Individuals whose responses to each item the MDQ improved by at least one grade at Test 1 (after consumption) and Test 2 (after consumption) compared with Test 1 (before consumption) and Test 2 (before consumption) 4. Individuals whose responses to "get irritated by trivial things," "feel anxious," "get sleepy during the day," "low concentration," "strong appetite," and "feel malaise" improved by at least one grade at Test 1 (after consumption) and Test 2 (after consumption) compared with Test 1 (before consumption) and Test 2 (before consumption) 5. Individuals who experienced adverse events

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026