UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039029 |
|---|---|
| Receipt number | R000044504 |
| Scientific Title | Association of taking herbal medicine including Citrus Unshiu Peel in HIV(human immunodeficiency virus) carriers who are using antiretroviral agents,with CD4 + T cell counts or QOL(quality of life) |
| Date of disclosure of the study information | 2019/12/28 |
| Last modified on | 2025/07/02 12:47:36 |
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Basic information
Public title
Association of taking herbal medicine including Citrus Unshiu Peel in HIV(human immunodeficiency virus) carriers who are using antiretroviral agents,with CD4 + T cell counts or QOL(quality of life)
Acronym
Association of taking herbal medicine including Citrus Unshiu Peel in HIV(human immunodeficiency virus) carriers who are using antiretroviral agents,with CD4 + T cell counts or QOL(quality of life)
Scientific Title
Association of taking herbal medicine including Citrus Unshiu Peel in HIV(human immunodeficiency virus) carriers who are using antiretroviral agents,with CD4 + T cell counts or QOL(quality of life)
Scientific Title:Acronym
Association of taking herbal medicine including Citrus Unshiu Peel in HIV(human immunodeficiency virus) carriers who are using antiretroviral agents,with CD4 + T cell counts or QOL(quality of life)
Region
| Japan |
Condition
Condition
HIV infectious disease
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To diagnose whether taking herbal medicine including Citrus Unshiu Peel can reduce or eliminate the side effects of ART,or will affect QOL or has a change in CD4 count.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To diagnose whether taking herbal medicine including Citrus Unshiu Peel can reduce or eliminate the side effects of ART.
Key secondary outcomes
Changes in QOL before and after administration of herbal medicine including Citrus Unshiu Peel for 1-3 months after administration.Changes in CD4 + T cell counts between 6 months before and after administration of herbal medicines including Citrus Unshiu Peel.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have good adherence to medication and have less than 200 copies / mL of HIV-RNA.
2.Patients who have been in ART for more than 6 months.
3.Patients who have been fully explained in participating in this study and have given written consent at their own will.
Key exclusion criteria
1.Patients with poor drug adherence.
2.Patients who take medication at irregular times and who have difficulty setting more than twice a day.
3. Women patients who are pregnant or possibly pregnant.
4.Patients whose serum potassium level is less than 3.5mEq/L.
5. Patients who take licorice-containing preparations and preparations containing glycyrrhizic acid and its salts.
6. Others patients who are deemed inappropriate by the research director or researchers.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Yanagi |
Organization
Tokai University School of Medicine
Division name
General Medicine Department of General Internal Medicine
Zip code
259-1193
Address
143 Shimokasuya,Isehara,Kanagawa
TEL
0463-93-1121
hidetakayanagi@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Sato |
Organization
Tokai University Hospital
Division name
Pharmacy Department,Division of Pharmacy
Zip code
259-1193
Address
143 Shimokasuya,Isehara,Kanagawa
TEL
0463-93-1121
Homepage URL
koichiro@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Institutional Review Board for Clinical Research,Tokai University
Address
143 Shimokasuya,Isehara,Kanagawa
Tel
0463-93-1121
tokai-rec@tsc.u-tokai.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
| 2019 | Year | 12 | Month | 28 | 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 | 12 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is intended for patients who are scheduled to administer,continue taking antiretroviral agents,and add any one of 6 herbal medicines(Kososan,Chotosan,Nichinto,Hochuekkito,Yokukansankachinpihange,Rikkunshito)as general medical care.
It is evaluated clinically whether side effects associated with ART are reduced or eliminated after administration of the herbal medicine.
The patient is required to fill out a QOL questionnaire twice on the day before of and 1 to 3 months after administration of the herbal medicine to evaluated the content.
The change in CD4 + T cell counts between the 6 months before and 6 months after the administration is evaluated.
Management information
Registered date
| 2019 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044504
