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
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
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
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
