UMIN-ICDS Clinical Trial

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

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Horphag Research (Asia) Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

NO

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)

Date of disclosure of the study information

2024

Year

04

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public 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 related information

Registered date

2024

Year

04

Month

19

Day

Last modified on

2024

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061893