UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050081 |
|---|---|
| Receipt number | R000056723 |
| Scientific Title | Effect of dried fruit on postoperative recovery in carpal tunnel release surgery |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2024/01/10 11:24:47 |
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Basic information
Public title
Effect of dried fruit on postoperative recovery in carpal tunnel release surgery
Acronym
Effect of dried fruit on postoperative recovery in carpal tunnel release surgery
Scientific Title
Effect of dried fruit on postoperative recovery in carpal tunnel release surgery
Scientific Title:Acronym
Effect of dried fruit on postoperative recovery in carpal tunnel release surgery
Region
| Japan |
Condition
Condition
Carpal tunnel syndrome
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of dried fruit in postoperative recovery in carpal tunnel release surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in motor nerve terminal latency.
Key secondary outcomes
-Sensory conduction velocity (SCV)
-visual analogue scale (VAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take about 50g of dried fruit1 per day for 3 months.
Interventions/Control_2
Take about 50g of dried fruit2 per day for 3 months.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects undergoing endoscopic carpal tunnel release surgery with a preoperative motor nerve terminal latency of 6 ms or more and a compound muscle action potential of 0.3 mV or more.
Key exclusion criteria
1. Person who has a history of carpal tunnel release surgery on the ipsilateral hand.
2. Persons with diabetes mellitus or cervical lesions, shingles, or undergoing dialysis treatment
3. Pregnant women, those who may be pregnant, those who are breastfeeding, and those who wish to become pregnant during the study period
4. Persons who have participated in other drug or food trials within the past month
5. Persons who have allergic reactions to fruits
6. Persons with serious diseases of the liver, kidney, heart, lungs, digestive organs, blood, endocrine system and metabolic system.
7. Persons who have been diagnosed with cardiovascular-related diseases such as atherosclerosis, angina pectoris, arrhythmia, etc., or psychiatric disorders such as depression
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-Machi, Haga-Gun Tochigi 321-3497, JAPAN
TEL
+81-285-68-7236
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sugita |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-Machi, Haga-Gun Tochigi 321-3497, JAPAN
TEL
+81-285-68-7236
Homepage URL
sugita.satoshi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata Hand Surgery Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
YES
Study ID_1
R.4-3
Org. issuing International ID_1
The ethical committee of Niigata Hand Surgery Foundation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟手の外科研究所病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 27 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056723
| Research Plan | |
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| Registered date | File name |
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