UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028360 |
|---|---|
| Receipt number | R000032468 |
| Scientific Title | Dose finding study of Cladosiphon okamuranus Fucoidan containing drink on improvement of Defecation in Healthy Subjects with Mild Constipation. A Randomized, Double-blind, Placebo-controlled, Parallel Study. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/07/25 09:56:22 |
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Basic information
Public title
Dose finding study of Cladosiphon okamuranus Fucoidan containing drink on improvement of Defecation in Healthy Subjects with Mild Constipation.
A Randomized, Double-blind, Placebo-controlled, Parallel Study.
Acronym
Dose finding study of Cladosiphon okamuranus Fucoidan containing drink on improvement of Defecation in Healthy Subjects with Mild Constipation.
Scientific Title
Dose finding study of Cladosiphon okamuranus Fucoidan containing drink on improvement of Defecation in Healthy Subjects with Mild Constipation.
A Randomized, Double-blind, Placebo-controlled, Parallel Study.
Scientific Title:Acronym
Dose finding study of Cladosiphon okamuranus Fucoidan containing drink on improvement of Defecation in Healthy Subjects with Mild Constipation.
Region
| Japan |
Condition
Condition
People tend to be constipated
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Calculation of effective dose of the drink containing Cladosiphon okamuranus Fucoidan on bowel movement of healthy subject who have a tendency to be constipated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency and days of defecation and amount of defecation will be measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A test drink containing high-dose Cladosiphon okamuranus Fucoidan per day for 2 Weeks.
Interventions/Control_2
A test drink containing low-dose Cladosiphon okamuranus Fucoidan per day for 2 Weeks.
Interventions/Control_3
A placebo drink(not containing Cladosiphon okamuranus Fucoidan) per day for 2 weeks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. People whose defecation frequency is no fewer than 3 nor more than 5.
2. Who usually have three meals a day.
3. Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria
People who meet any of the following conditions will be excluded.
1. Who regularly use intestinal drugs and laxative (including strong laxatives and enema)
2. Who can not stop intake the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) during the screening period.
3. Who use medicine such as antibiotics that affect digestion and absorption.
4. Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period.
5. Who have allergic to food.
6. Who have serious diseases requiring an urgent treatment, or who accept severe complication.
7. Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy).
8. Who are judged unsuitable for this study based on subject questionnaire.
9. Who is pregnant or willing to be pregnant or brest-feeding during this study.
10. Who has a current or history of drug dependence and/or alcoholism.
11. Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that.
12. Who are judged unsuitable for this study by test responsibility doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhi Sugimura |
Organization
C'est la vie Shinbashi Clinic
Division name
Medical Office
Zip code
Address
2-39-3 Shinbashi, Minato-ku, Tokyo
TEL
03-5408-8181
h-sugimura@shinkokai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales Department
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
SOUTH PRODUCT Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Fisheries Division, Department of Agriculture, Forestry and Fisheries, Okinawa Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 08 | 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
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 16 | 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
| 2017 | Year | 07 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032468
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