UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054202 |
|---|---|
| Receipt number | R000061893 |
| Scientific Title | Effects of consumption of the test food on common menstrual complaints in healthy Japanese women: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/04/19 |
| Last modified on | 2024/08/21 10:03:17 |
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Basic information
Public title
Effects of consumption of the test food on common menstrual complaints in healthy Japanese women
Acronym
Effects of consumption of the test food on common menstrual complaints in healthy Japanese women
Scientific Title
Effects of consumption of the test food on common menstrual complaints in healthy Japanese women: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on common menstrual complaints in healthy Japanese women
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this trial is to verify the effects of consumption of the test food for 4 menstrual cycles (approximately 16 weeks) on common premenstrual complaints in healthy Japanese females with a primary focus on mood symptoms of irritability and anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the score of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese
2. Female
3. Subjects aged 20 ~ 40
4. Healthy subjects
5. Subjects who have common menstrual complaints
6. Subjects whose menstrual cycle is between 25 and 38 days
7. Subjects whose lasting period of the menstruation is between 3 and 7 days
8. Subjects whose score of Neg Affect in the MDQ (before menstruation) is high at Scr
Key exclusion 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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Horphag Research (Asia) Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
88
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061893
