UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024674 |
|---|---|
| Receipt number | R000028388 |
| Scientific Title | Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2017/01/05 12:55:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Acronym
Effect of ingestion of Moringa oleifera leaves on improving constipation.
Scientific Title
Effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Scientific Title:Acronym
Effect of ingestion of Moringa oleifera leaves on improving constipation.
Region
| Japan |
Condition
Condition
Healthy adult female with a tendency for constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of consecutive ingestion of Moringa oleifera leaves on improving constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation days,defecation frequency,fecal amount
Key secondary outcomes
Fecal shape,fecal color,fecal odor,feeling after defecation,intestinal microflora
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested the placebo powder for 2 weeks, after 2 weeks, ingested the Moringa oleifera leaves powder for 2 weeks.
Interventions/Control_2
The subjects ingested the Moringa oleifera leaves powder for 2 weeks, after 2 weeks, ingested the placebo powder for 2 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Subjects whose defecation frequency is no fewer than 3, nor more than 6,
2.Subjects who not consume higher amount of alcohol
3.Subjects whose meal times are three a day usually.
Key exclusion criteria
1.Subjects who regularly use intestinal drug and laxatives(including strong laxatives).
2.Subjects who can not stop intake higher amount of food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or the health food to relieve constipation during the screening period.
3.Subjects who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement.
4.Subjects who is pregnant or willing to be pregnant or breast-feeding during this study.
5.Subjects who are judged unsuitable for this study by test responsibility doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mihoko Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
Address
2-3-1 konodai, Ichikawa, Chiba, 272-8533 Japan
TEL
047-371-2393
moto@wayo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mihoko Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
Address
2-3-1 konodai, Ichikawa, Chiba, 272-8533 Japan
TEL
047-371-2393
Homepage URL
moto@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
iGUAZU Corporation
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 01 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028388
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
