UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052717 |
|---|---|
| Receipt number | R000060139 |
| Scientific Title | A placebo-controlled double-blind study of pain level reduction by ingestion of test food in healthy participant |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2023/11/07 15:32:08 |
* 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 evaluation test on pain by ingestion of test food
Acronym
Pain level reduction tes
Scientific Title
A placebo-controlled double-blind study of pain level reduction by ingestion of test food in healthy participant
Scientific Title:Acronym
Pain level reduction test
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pain level reduction on headache and menstrual pain is measured before and after intake of the test food (12 weeks), and compared with placebo or before intake in a placebo-controlled double-blind study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 10g / day of placebo food for 12 weeks.
Interventions/Control_2
Intake 10g / day of test food A for 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy people aged 20-65 years.
2) A person who is assumed to be able to receive, agree and complete all explanations.
3) Healthy Japanese suffering from headaches or menstrual pain.
Key exclusion criteria
1) Pregnant or breastfeeding
2) Those who are prone to anemia
3) Those who are continuously receiving treatment and taking medication for illness
4) Those with a history of cardiovascular disease or renal function
5) Those with nervous system diseases or metabolic disorders
6) Those who are judged to be ineligible by the investigator
7) Those who are taking medication other than the above that may affect the test results
8) Those who have already participated in other clinical trials
9) Those who have taken collagen continuously within one month before starting this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Murata |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
me-murata@nitta-gelatin.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Murata |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
Homepage URL
me-murata@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Co-creation Association AMC Nishiumeda Clinic Research Ethics Review Committee
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
morikawa@amc-clinic.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
| 2025 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060139
