UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029525
Receipt number R000031244
Scientific Title A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on preoperative anemia and fatigue, insomnia and anxiety in patients who recieve gynecologic operation
Date of disclosure of the study information 2017/11/01
Last modified on 2023/02/24 10:06:52

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Basic information

Public title

A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on preoperative anemia and fatigue, insomnia and anxiety in patients who recieve gynecologic operation

Acronym

A prospective interventional study of Ninjin-Youei-To on preoperative anemia and fatigue, isomnia and anxiety

Scientific Title

A prospective interventional study of Japanese herbal medicine, Ninjin-Youei-To on preoperative anemia and fatigue, insomnia and anxiety in patients who recieve gynecologic operation

Scientific Title:Acronym

A prospective interventional study of Ninjin-Youei-To on preoperative anemia and fatigue, isomnia and anxiety

Region

Japan


Condition

Condition

Patients who recieve gynecologic operation
Anemia

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of Ninjin-Youei-To on preoperative anemia, fatigue, insomnia and anxiety in patients who recieve gynecologic operation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

anemia:Hb
compare at four weeks before operation and at the previous operation day

Key secondary outcomes

fatigue:CFS Cancer Fatigue Scale
insomnia:PSQI Pittsburgh Sleep Quality Index
anxiety:VAS scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ferromia for 4 weeks

Interventions/Control_2

Ninjin-Youei-To
Ferromia for 4 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


Not applicable

Gender

Female

Key inclusion criteria

Female patients who recieve gynecologic operation and take Ferromia by diagnosing as anemia(Hb<11 g/dl)

Key exclusion criteria

1) Patients with concomitant use of other Japanese herbal medicine
2) Patients with use of Japanese herbal medicine for fatigue, insomnia and anxiety within two weeks
3) Patients with depression
4) Patients with aldosteronism, myopathy and hypokalemia
5) Patients with liver dysfunction
6) Patients who are inappropriate to participate in the study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Kimura

Organization

Osaka University Graduate School of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3351

Email

tadashi@gyne.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Mayuko
Middle name
Last name Miyamoto

Organization

Osaka University Graduate School of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3351

Homepage URL


Email

mmiyamoto-wak@umin.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

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

Osaka University Clinical Research Review Committee

Address

2-2 Yamadaoka, Suita, Osaka

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.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

2017 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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

2017 Year 10 Month 12 Day

Date of IRB

2023 Year 01 Month 25 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2022 Year 10 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 10 Month 12 Day

Last modified on

2023 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031244


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name