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
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
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
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
