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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000019732 |
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Date of registration:
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11/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
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Scientific title:
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A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. - The high-dose EGCG therapy for AL-Amyloidosis. |
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Date of first enrolment:
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2015/03/31 |
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Target sample size:
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60 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022783 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Sohsuke Meshitsuka |
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Address:
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4-1-22 hiroo sibuya tokyo
Japan |
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Telephone:
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03-3400-1311 |
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Email:
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meshitsuka_sosuke@med.jrc.or.jp |
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Affiliation:
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Japanese Red Cross Medical Center Division of Hematology |
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Name:
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Sohsuke Meshitsuka |
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Address:
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4-1-22 hiroo sibuya tokyo
Japan |
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Telephone:
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03-3400-1311 |
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Email:
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meshitsuka_sosuke@med.jrc.or.jp |
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Affiliation:
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Japanese Red Cross Medical Center Division of Hematology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ligh chain amyloidosis
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Source(s) of Monetary Support
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no
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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