UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055185 |
|---|---|
| Receipt number | R000058049 |
| Scientific Title | Acupuncture for low food intake |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2024/08/07 12:03:16 |
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Basic information
Public title
Acupuncture for low food intake
Acronym
Acupuncture for low food intake
Scientific Title
Acupuncture for low food intake
Scientific Title:Acronym
Acupuncture for low food intake
Region
| Japan |
Condition
Condition
Reduced food intake during hospitalization
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study demonstrates the improvement of food intake by acupuncture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in food intake before and after acupuncture intervention for one week
Key secondary outcomes
Changes in food intake for each of the three meals before and after acupuncture intervention,
Changes in measured values of prealbumin, total cholesterol, nutritional prognostic index, hemoglobin, and C-reactive protein in patients with nutrition support team intervention
Safety (presence or absence of adverse events)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From February 1, 2020 to January 31, 2023, among the patients who received acupuncture treatment during hospitalization at the Kumamoto Red Cross Hospital for decreased food intake,
Subjects whose average food intake during the week before treatment is less than 50%.
Key exclusion criteria
Subjects who cannot observe food intake for 3 days before and after acupuncture treatment.
Those who are managed by tube feeding.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Mitani |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of general internal medicine
Zip code
8618520
Address
2-1-1,Nagamineminami,Higashi-ku,Kumamoto city, Kumamoto prefecture
TEL
096-384-2111
mia70.hari@gmail.com
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Mitani |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of general internal medicine
Zip code
861820
Address
2-1-1,Nagamineminami,Higashi-ku,Kumamoto city, Kumamoto prefecture
TEL
0963842111
Homepage URL
mita70.hari@gmail.com
Sponsor or person
Institute
Japanese Red Cross Kumamoto Hospital
Institute
Department
Personal name
Mitani Naoya
Funding Source
Organization
Japanese Red Cross Kumamoto Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Kumamoto Hospital
Address
2-1-1,Nagamineminami,Higashi-ku,Kumamoto city, Kumamoto prefecture
Tel
0963842111
rinsyoukenkyu@kumamoto-med.jrc.or.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
熊本赤十字病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 07 | 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
80
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
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Informed consent was obtained by sending a "study description and consent form" to the subjects, who provided written confirmation. If the subject was unable to respond or had passed away, a legal representative signed and returned the form. The subjects of this study were hospitalized patients who received acupuncture treatment for reduced food intake, specifically those whose average food intake was less than 50% up to seven days before the start of treatment and who consented to acupuncture. Patients who did not provide consent, those whose food intake could not be observed for three days before and after acupuncture, and those receiving enteral nutrition were excluded from the study.
The primary outcome was the change in the rate of increase in food intake over the seven days before and after acupuncture treatment. Secondary outcomes included changes in the rate of increase in food intake for each meal, changes in blood parameters (TLC, HGB, ALB, PALB) before and after acupuncture, and the evaluation of the safety of acupuncture treatment. Nurses independently assessed food intake, recording the amounts of staple and side dishes consumed at breakfast, lunch, and dinner on a ten-point scale in the medical records. Acupuncturists referred to this recorded information and summed the intake amounts from the three meals to determine the daily food intake. Since the maximum total for the three meals is 60, the daily food intake ratio was calculated by dividing the total by 60 and multiplying by 100. The food intake rates over the seven days before and after acupuncture were plotted on graphs, and approximate linear lines were drawn. The slope of these lines was used to determine the rate of change in daily food intake.
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058049
