UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022417
Receipt number R000025484
Scientific Title A study to test the efficacy of "mulberry leaf green juice" in improving constipation in pregnant females.
Date of disclosure of the study information 2016/05/25
Last modified on 2020/06/01 16:01:54

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Basic information

Public title

A study to test the efficacy of "mulberry leaf green juice" in improving constipation in pregnant females.

Acronym

A study to test the efficacy of "mulberry leaf green juice" in improving constipation.

Scientific Title

A study to test the efficacy of "mulberry leaf green juice" in improving constipation in pregnant females.

Scientific Title:Acronym

A study to test the efficacy of "mulberry leaf green juice" in improving constipation.

Region

Japan


Condition

Condition

People tend to be constipated

Classification by specialty

Gastroenterology Obstetrics and Gynecology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the safety and efficacy in ameliorating constipation of green mulberry leaf juice administered for 2 to 12 weeks in pregnant women suffering from constipation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Daily defecation frequency
(amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defection)

Key secondary outcomes

Intestinal bacteria flora
Dietary survey (The brief-type self-administered diet history questionnaire)
Questionnaire survey
Safety assessment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

Ingested food : Mulberry leaf green juice
Dose : Two packets per day Drink
Usage : The content of each package should be fully dissolved in 100 to 180 mL of cold or hot water before ingestion.
Period : 2-12 weeks

Interventions/Control_2

Ingested drugs : Magnesium oxide
Dose : 1.5 g per day
Usage : The control product should be taken with water at a daily dose of 1.5 g in 3 divided doses, or in a single dose before going to bed.
Period : 2-12 weeks

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

18 years-old <=

Age-upper limit

45 years-old >

Gender

Female

Key inclusion criteria

1) Pregnant women aged 18 to < 45 years reporting constipation.
2) Those who express their willingness to participate in the study and provide consent for participation after understanding the purpose and details of the study.
3) Those who can continue to undergo antenatal checkups at the study site.

Key exclusion criteria

1) Those currently attending the hospital for the treatment of other diseases.
2) Those with diseases that might affect the results of assessment in this study.
3) Those currently taking foods or green juice containing mulberry leaf regularly.
4) Those currently participating in another clinical trial or have participated in another clinical trial within 3 months prior to the start of the present study.
5) Other women judged by the attending physicians as being inappropriate candidates for inclusion in the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuna
Middle name
Last name Watanabe

Organization

Niigata University of Health and Welfare

Division name

Department of Health and Nutrition

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN

TEL

025-257-4494

Email

yuna-watanabe@nuhw.ac.jp


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name Ando

Organization

NATURAL SCIENCE CORPORATION

Division name

Research and Development Department

Zip code

136-0037

Address

3F NATURAL FACTORY TOKYO, 3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN

TEL

03-5665-2311

Homepage URL


Email

ando@natural-s.jp


Sponsor or person

Institute

Natural Science Co.,Ltd.
Research and Development Department

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Healthcare Systems Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University of Health and Welfare IRB

Address

1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN

Tel

025-257-4455

Email

eri-sakata@nuhw.ac.jp


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

よしかた産婦人科 (神奈川県)
Yoshikata Obsterics and Gynecology Clinic (Kanagawa)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 25 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

To be reported at the 33rd Annual Scientific Meeting of the Japan Society for Menopause and Women's Health, November 3-4, 2018

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

Completed

Date of protocol fixation

2016 Year 03 Month 28 Day

Date of IRB

2016 Year 04 Month 20 Day

Anticipated trial start date

2016 Year 06 Month 20 Day

Last follow-up date

2018 Year 04 Month 24 Day

Date of closure to data entry

2018 Year 07 Month 30 Day

Date trial data considered complete


Date analysis concluded

2018 Year 10 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 23 Day

Last modified on

2020 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025484


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name