UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039882 |
|---|---|
| Receipt number | R000045481 |
| Scientific Title | Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2023/03/31 10:13:23 |
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Basic information
Public title
Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study
Acronym
Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study
Scientific Title
Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study
Scientific Title:Acronym
Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Geriatrics | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Ninjin'yoeito in oral frailty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of subjective symptoms in questionnaire
Key secondary outcomes
1. Severity score of symptoms: Physical strength decline after illness or operation, fatigue/ malaise, loss of appetite, night sweat, coldness of hands and feet, or anemia.
2. Moitening of oral mucosa
3. RSST (Repetitive saliva swallowing test)
4. VAS (Visual Analogue Scale) of taste
5. Peripheral blood flow and blood flow velocity
6. Function of NK (Natural Killer) cell
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients having at least one indications for Ninjin'yoeito: Physical strength decline after illness or operation, fatigue/ malaise, loss of appetite, night sweat, coldness of hands and feet, or anemia.
2. Over 64 years old patients.
3. Outpatients with walking alone possibility.
4. Patients with oral frailty.
Key exclusion criteria
1. Patients having taking Kampo formula with supplemental effect in the post 2 weeks.
2. Smoker in the post 1 year.
3. Patients having past history or suspicion of aldosteronism, myopathy, or hypokalemia.
4. Patients diagnosed as having the following: severe heart disease, kidney disease, or endocrine metabolic disease.
5. Patients considered inappropriate for this trial by the physicians-in-charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Yoshizaki |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Division of Otolaryngology, Head and Neck Surgery
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa-city, Ishikawa
TEL
076-265-2413
tomoy@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Shirai |
Organization
Kanazawa University Hospital
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa-city, Ishikawa
TEL
076-265-2413
Homepage URL
shiraiaki@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Head and Neck Surgery
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
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
Independent Ethics Committee in Graduate School of Medical Sciences, Kanazawa University
Address
13-1 Takaramachi, Kanazawa-city, Ishikawa
Tel
076-265-2832
rinri@adm.kanazawa-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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | 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
13
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
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study evaluates the efficacy of Ninjin'yoeito for oral frailty by severity score of symptoms, moitening of oral mucosa, RSST, score of subjective symptoms in questionnaire, VAS of taste, peripheral blood flow and blood flow velocity, and function of NK (Natural Killer) cell before treatment and 4, 8, 12 weeks after treatment.
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045481
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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