A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.

A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. - The high-dose EGCG therapy for AL-Amyloidosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019732

Enrollment

Registered

2015-11-11

Start date

2015-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ligh chain amyloidosis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactSohsuke Meshitsuka

Japanese Red Cross Medical Center Division of Hematology

meshitsuka_sosuke@med.jrc.or.jp03-3400-1311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026