UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022417
Receipt No. 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 (Ver. 8)

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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 Obsterics 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
Institute Natural Science Co.,Ltd.
Research and Development Department
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025484