Unique ID issued by UMIN | UMIN000039029 |
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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 | 2023/12/30 14:49:05 |
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)
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)
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)
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)
Japan |
HIV infectious disease
Infectious disease |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
To diagnose whether taking herbal medicine including Citrus Unshiu Peel can reduce or eliminate the side effects of ART.
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
30
1st name | Hidetaka |
Middle name | |
Last name | Yanagi |
Tokai University School of Medicine
General Medicine Department of General Internal Medicine
259-1193
143 Shimokasuya,Isehara,Kanagawa
0463-93-1121
hidetakayanagi@gmail.com
1st name | Koichiro |
Middle name | |
Last name | Sato |
Tokai University Hospital
Pharmacy Department,Division of Pharmacy
259-1193
143 Shimokasuya,Isehara,Kanagawa
0463-93-1121
koichiro@tokai.ac.jp
Tokai University
Other
Other
Institutional Review Board for Clinical Research,Tokai University
143 Shimokasuya,Isehara,Kanagawa
0463-93-1121
tokai-rec@tsc.u-tokai.ac.jp
NO
2019 | Year | 12 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 12 | Month | 21 | Day |
2019 | Year | 12 | Month | 25 | Day |
2019 | Year | 12 | Month | 25 | Day |
2024 | Year | 12 | Month | 31 | Day |
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.
2019 | Year | 12 | Month | 28 | Day |
2023 | Year | 12 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044504
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