UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000061811
Receipt number	R000070728
Scientific Title	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
Date of disclosure of the study information	2026/06/05
Last modified on	2026/06/05 09:09:19

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To verify the effects of consumption of the test food on premenstrual dysphoric disorder in healthy adult women.

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 score of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the examination after consumption

Key secondary outcomes

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

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

<Duration>
One menstrual cycle (two times)
<Test product>
Test 1: Test food (food containing inositol)
Test 2: Placebo (food not containing inositol)
<Administration>
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 should not be carried over to the following day.
*The intervention sequence is Test 1 to Test 2.
*The washout period is at least one menstrual cycle.

Interventions/Control_2

<Duration>
One menstrual cycle (two times)
<Test product>
Test1: Placebo (food not containing inositol)
Test2: Test food (food containing inositol)
<Administration>
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 should not be carried over to the following day.
*The intervention sequence is Test 1 to Test 2.
*The washout period is at least one menstrual cycle.

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

39 years-old >=

Gender

Female

Key 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

Key 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

Target sample size

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

Email

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

Email

nao@orthomedico.jp

Sponsor or person

Institute

Tsuno Rice Fine Chemicals Co., Ltd.

Institute

Department

Personal name

Funding Source

Organization

Tsuno Rice Fine Chemicals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

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

Email

IRB@takara-clinic.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

2026 Year 06 Month 05 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

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

Open public recruiting

Date of protocol fixation

2026 Year 05 Month 27 Day

Date of IRB

2026 Year 05 Month 27 Day

Anticipated trial start date

2026 Year 06 Month 05 Day

Last follow-up date

2026 Year 12 Month 05 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2026 Year 06 Month 05 Day

Last modified on

2026 Year 06 Month 05 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070728