UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037409 |
|---|---|
| Receipt number | R000042643 |
| Scientific Title | Effect of the supplement on edma of the lower limbs in healthy females - A randomized controlled trial - |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2020/03/26 12:13:42 |
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Basic information
Public title
Effect of the supplement on edma of the lower limbs in healthy females
- A randomized controlled trial -
Acronym
Effect of the supplement on edma of the lower limbs in healthy females
Scientific Title
Effect of the supplement on edma of the lower limbs in healthy females
- A randomized controlled trial -
Scientific Title:Acronym
Effect of the supplement on edma of the lower limbs in healthy females
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of supplement on edma of the lower limbs in healthy females aged between 20 and 40 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire for the edma of lower limbs
Key secondary outcomes
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food A: 8 tablets/day for 1 week
Interventions/Control_2
Test food B: 2 tablets/day for 1 week
Interventions/Control_3
Test food C: 1 tablets/day for 1 week
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1)Healthy Japanese females aged 20 to 40 years of age at the time of the informed consent.
2)Subject with systolic blood pressure less than 130 mmHg at SCR.
3)Subject who is currently aware of the edema of lower limbs.
4)Subject who has understood the purpose of the study,and agreed to participate by signing the written informed consent.
Key exclusion criteria
1)Subject with BMI <= 18.5 kg/m2 and >30 kg/m2.
2)Subject who is taking medication or who is currently under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food (especially milk allergy) .
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness (depression) or sleep disturbance.
7)Subject whose lifestyle is extremely irregular.
8)Subject who has an unbalanced diet.
9)Subject who has serious illness or history such as immune disease, brain disease, malignant tumor, diabetes, liver disease (hepatitis), kidney disease or heart disease, thyroid disease, adrenal disease or other metabolic disease.
10)Subject who cannot stop using the health foods, supplements and medicines that may affect edema and fatigue of lower limbs such as Melilotus extract, long pepper extract, BCAA (branched chain amino acid) during the test period.
11)Subject who cannot stop using products to treat the edema of the lower limbs (pressure socks or stockings, and other tings alike) during the study period.
12)Subject who cannot stop taking food and drinks that is specified as health food or food with functional claims, that may affect the edma of the lower limbs during the study period.
13)Subject who cannot stop taking other medications (including Chinese medicine) or supplements during the study period.
14)Subject who has participated in other clinical studies within the last 3 months or is planning to participate in other clinical studies during the study period.
15)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
16)Subject who cannot keep the daily records.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health Science Research Center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3510
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
102
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
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042643
