UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052572 |
|---|---|
| Receipt number | R000059985 |
| Scientific Title | The effects of Yuzhu ointment on immune function in an elderly population |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2023/10/22 02:27:01 |
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Basic information
Public title
The effects of Yuzhu ointment on immune function in an elderly population
Acronym
Yuzhu and immune function
Scientific Title
The effects of Yuzhu ointment on immune function in an elderly population
Scientific Title:Acronym
Yuzhu and immune function
Region
| Asia(except Japan) |
Condition
Condition
Immunosenescence
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of Yuzhu ointment on immune function and mechanism in the elderly population.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Leukocyte typing assays, and exploration of potential mechanisms by serum metabolome, proteomics, and fecal genomics and metabolomics
Key secondary outcomes
Telomerase activity and telomere length in blood leukocytes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Yuzhu ointment 20 ml per day
Interventions/Control_2
1% Yuzhu ointment 20 ml per day
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
| 60 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The elderly living independently in the community.
Key exclusion criteria
1. Patients with severe depression, severe dementia and the elderly with visual or hearing impairment;
2. Patients with serious cardiovascular and cerebrovascular diseases (coronary heart disease, stroke and myocardial infarction, etc.), tumors, liver and kidney diseases, etc.;
3. History of asthma, allergy, etc.;
4. The elderly who cannot complete the follow-up, such as scheduled relocation during the follow-up period.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | kaijun |
| Middle name | |
| Last name | Niu |
Organization
Tianjin University of Traditional Chinese Medicine.
Division name
School of Public Health of Tianjin University of Traditional Chinese Medicine
Zip code
301617
Address
10 Poyanghu Road, West Area, Tuanbo New Town, Jinghai District, Tianjin, China.
TEL
+86-22-59596296
nkj0809@gmail.com
Public contact
Name of contact person
| 1st name | Tingting |
| Middle name | |
| Last name | Xia |
Organization
Tianjin University of Traditional Chinese Medicine.
Division name
Tianjin University of Traditional Chinese Medicine.
Zip code
301617
Address
10 Poyanghu Road, West Area, Tuanbo New Town, Jinghai District, Tianjin, China.
TEL
+86-22-59596296
Homepage URL
nkj0809@gmail.com
Sponsor or person
Institute
School of Public Health of Tianjin University of Traditional Chinese Medicine.
Institute
Department
Personal name
Funding Source
Organization
National Key Research and Develepment Program of China.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tianjin University of Chinese Medicine, Second affiliated hospital.
Address
10 Poyang Lake Road, West District of Tuanpo New Town, Jinghai District, Tianjin. China.
Tel
+86-22-59596296
nkj0809@gmail.com
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
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059985
