UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047591 |
|---|---|
| Receipt number | R000054272 |
| Scientific Title | Efficacy and safety of acupuncture on anorexia and dietary intake loss in patients with chronic respiratory disease (randomized controlled trial) |
| Date of disclosure of the study information | 2022/04/26 |
| Last modified on | 2022/04/26 00:27:04 |
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Basic information
Public title
Effects of Acupuncture Therapy on Anorexia in Chronic Pulmonary diseases
Acronym
EAT-ACUP trial
Scientific Title
Efficacy and safety of acupuncture on anorexia and dietary intake loss in patients with chronic respiratory disease (randomized controlled trial)
Scientific Title:Acronym
Effects of acupuncture on anorexia in Chronic respiratory disease (RCT)
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of acupuncture to improve anorexia and dietary intake loss, and to maintain body weight among patients with chronic respiratory diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score for appetite
Key secondary outcomes
1) Food intake
2) Body Mass Index
3) nutrition status (Alb, Pre-Alb, retinol-binding protein)
4) 24-hour heart rate variability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture group (group that adds acupuncture to standard treatment)
Twice a week for 5 weeks
Interventions/Control_2
Control group (normal treatment group)
5 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic respiratory disease who have very low food intake due to loss of appetite
2) Patients with weight loss (5% or more / 6 months) or low BMI (<20 kg / m2)
3) Patients who consented in writing
4) Patients who the doctor has determined to be stable.
Key exclusion criteria
1) Patients with malignant tumors
2) Patients with serious heart disease
3) Patients with severe liver dysfunction
4) Patients with severe renal dysfunction
5) Patients with severe asthma factors
6) Patients with collagen disease (RA, PM / DM, etc.)
7) Patients who have undergone drug changes during clinical trials
8) Patients who have already received acupuncture
9) Patient judged as inappropriate by the researchers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kida |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka
TEL
+81668532001
kida.hiroshi.sv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Maekura |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Respiratory Science Laboratory
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
TEL
+81668532001
Homepage URL
maekura.acupuncture@gmail.com
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Clinical Research from National Hospital Organization in Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
Tel
+81668532001
410-chiken@mail.hosp.go.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
| 2022 | Year | 04 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054272
