Unique ID issued by UMIN | UMIN000019732 |
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Receipt number | R000022783 |
Scientific Title | A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. |
Date of disclosure of the study information | 2015/11/11 |
Last modified on | 2016/08/05 09:47:18 |
A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
The high-dose EGCG therapy for AL-Amyloidosis.
A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
The high-dose EGCG therapy for AL-Amyloidosis.
Japan |
ligh chain amyloidosis
Hematology and clinical oncology |
Others
NO
Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with light-chain amyloidosis. Evaluation of clinical efficacy of EGCG intake.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
compare the 3 and 6 month change in each organ involvement such as cardiac troponin T, NT-proBNP, interventricular septum thickness, ejection fraction, quantitative immunoglobulins, serum beta2 microglobulin, serum-free light chains, urinary albumin, derivatives of reactive oxygen metabolites, and biochemical antioxidant potential.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Diagnosis
Food |
standerd therapy plus the high dose green tea therapy.
Drug: green tea extract powder
Pharmaceutical formulation: capsules
dose 2400 mg/d p.o. for 6 months every day
standerd therapy
20 | years-old | <= |
Not applicable |
Male and Female
1. Biopsy proven systemic AL amyloidosis.
2. At least one evaluable organ involvement.
3. Ability of subject to understand character and individual consequences of the clinical trail.
4. Written informed consent.
5. Ability of subject to intake capsules.
1.Age less than 20 years.
2.Not able to visit Japanese Red Cross Medical Center every 3 months.
3.History of any hypersensitivity or allergic reactions to the green tea ingredients.
60
1st name | |
Middle name | |
Last name | Sohsuke Meshitsuka |
Japanese Red Cross Medical Center
Division of Hematology
4-1-22 hiroo sibuya tokyo
03-3400-1311
meshitsuka_sosuke@med.jrc.or.jp
1st name | |
Middle name | |
Last name | Sohsuke Meshitsuka |
Japanese Red Cross Medical Center
Division of Hematology
4-1-22 hiroo sibuya tokyo
03-3400-1311
meshitsuka_sosuke@med.jrc.or.jp
Japanese Red Cross Medical Center, Division of Hematology
no
Other
NO
2015 | Year | 11 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 21 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 11 | Month | 10 | Day |
2016 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022783
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