UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044859
Receipt number R000051215
Scientific Title Effects of acupuncture for anorexia and dietary intake loss in patients with advanced respiratory illness (Pilot study)
Date of disclosure of the study information 2021/07/14
Last modified on 2021/07/14 12:25:33

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Basic information

Public title

Effects of acupuncture for anorexia and dietary intake loss in patients with advanced respiratory illness (Pilot study)

Acronym

Effects of acupuncture on anorexia in advanced respiratory disease

Scientific Title

Effects of acupuncture for anorexia and dietary intake loss in patients with advanced respiratory illness (Pilot study)

Scientific Title:Acronym

Effects of acupuncture on anorexia in advanced respiratory disease

Region

Japan


Condition

Condition

advanced respiratory illness

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether acupuncture improves dietary intake through increased appetite stimulation, and maintains weight, and to evaluate the safety of acupuncture in patients with advanced respiratory illness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

amount of food intake before and after acupuncture (three times a week for 3 weeks)

Key secondary outcomes

1) VAS score for appetite
2) nutrition status (Alb, Pre-Alb, retinol-binding protein)
3) appetite hormone (ghrelin)
4) catecholamines (norepinephrine, epinephrine, and dopamine)
5) 24-hour urinary catecholamine levels.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

acupuncture three times a week for 3 weeks.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) severe chronic respiratory diseases
2) extremely reduced dietary intake due to poor appetite, despite receiving nutritional therapy
3) body weight loss of more than 5% in the last 6 months or BMI < 21 kg/m2
4) Patients who have signed the agreement for participation in this study

Key exclusion criteria

1) Patients with malignant tumours
2) Patients with serious cardiac disease
3) Patients with hepatic insufficiency
4) Patients with renal insufficiency
5) Patients whose drugs have been changed during the clinical trial
6) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Ryoji
Middle name
Last name Maekura

Organization

Graduate School of Medical Safety Management, Jikei University of Health Care Sciences

Division name

Jikei University of Health Care Sciences

Zip code

532-0003

Address

1-2-8 Miyahara, Yodogawa-ku, Osaka, Japan

TEL

06-6150-1336

Email

r-maekura@ghsj.ac.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

Division of clinical reserach, laboratory of respiratory sciencekennkyuuinn

Zip code

560-8552

Address

5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan

TEL

06-6853-2001

Homepage URL


Email

m_tomonori@me.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

06-6853-2001

Email

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

2021 Year 07 Month 14 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

10

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

2016 Year 09 Month 01 Day

Date of IRB

2016 Year 09 Month 16 Day

Anticipated trial start date

2016 Year 10 Month 01 Day

Last follow-up date

2020 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 14 Day

Last modified on

2021 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051215


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name