Effects of consumption of the test food on common menstrual complaints in healthy Japanese women

UMIN ID: UMIN000054202

Registered date:19/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/04/19
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Approximately 16 weeks (menstrual cycle x 4 = 100-152 days) Test food: Pycnogenol (R) Administration: After the enrollment is confirmed, take 2 capsules per day with water or warm water, starting 7 days after the first menstruation begins, through 4 menstrual cycles, and until 7 days after the fifth menstruation begins. *Daily dose should be taken within the day with food. If a dose is missed, take it as soon as you remember within that day. Avoid carrying over a dose to the following day.
Duration: Approximately 16 weeks (menstrual cycle x 4 = 100-152 days) Test food: Starch (Placebo) Administration: After the enrollment is confirmed, take 2 capsules per day with water or warm water, starting 7 days after the first menstruation begins, through 4 menstrual cycles, and until 7 days after the fifth menstruation begins. *Daily dose should be taken within the day with food. If a dose is missed, take it as soon as you remember within that day. Avoid carrying over a dose to the following day.

Outcome(s)

• Primary Outcome: 1. The measured value of the score of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination.
• Secondary Outcome: 1. The amount of change and rate of change of the score of Neg Affect in the MDQ (before menstruation) between Scr and the 2nd examination. 2. The measured value of the score of Neg Affect in the MDQ (before menstruation) at the 1st examination, the amount of change and rate of change of the score of Neg Affect in the MDQ (before menstruation) between Scr and the 1st examination. 3. The measured value of the score of Neg Affect in the MDQ (during and after menstruation) at the 1st and the 2nd examination, the amount of change and rate of change of the score of Neg Affect in the MDQ (during and after menstruation) between Scr and the 1st or the 2nd examination. 4. The measured value of the score of each scale (Pain, Water Reten, Auto React, Impair Conc, Behave Change, Arousal, Control) in the MDQ (before, during and after menstruation) at the 1st and the 2nd examination, the amount of change and rate of change of the score of the in the above scales in the MDQ (before, during and after menstruation) between Scr and the 1st or the 2nd examination. 5. Each item in the MDQ at the 1st and the 2nd examination. 6. The measured value of the score of each item of the Premenstrual Tension Syndrome-Visual Analogue Scale (PMTS-VAS) at the 1st and the 2nd examination, the amount of change and rate of change of each item of the PMTS-VAS between Scr and the 1st or the 2nd examination.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Female
• Exclude criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are undergoing medical treatment or have a medical history of gynopathy {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial carcinoma, and ovarian cancer} 5. Subjects who are undergoing medical treatment or have a medical history of immune system disorders (such as multiple sclerosis, lupus erythematosus, and other autoimmune diseases) 6. Subjects who have severe menstrual pain that cannot be controlled with analgesics 7. Subjects who are undergoing medical treatment or have a medical history of psychiatric disorder 8. Subjects who receive hormonal therapy 9. Subjects who are currently taking low dosage pill (oral contraceptive) 10. Postmenopausal subjects 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage 12. Subjects regularly taking medications (including herbal medicines) and supplements 13. Subjects who are allergic to medications and/or the test food related products, especially those who are allergic to pine trees 14. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period 15. Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period 16. Subjects who are deemed ineligible to participate by the principal investigator

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Horphag Research (Asia) Limited