A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies

A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies - A crossover trial of EGCS for patients with dystrophinopaties

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005945

Enrollment

Registered

2011-07-19

Start date

2011-07-01

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

Dystrophinopathies (Duchenne/Becker muscular dystrophy)

Interventions

1st phase (12w) EGCS 5mg/kg twice/day, washout (2-4w), 2nd phase (12w) placebo twice/day 1st phase (12w) placebo twice/day, washout (2-4w), 2nd phase (12wa) EGCS 5mg/kg twice/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Genetically or immunologically diagnosed dystrophinopathies 2. Serum CK>1000 U/L 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Serious other organ disoreders (heart, respiration, liver, kidney, etc) 2. Further physiological or neurological disorders, active illness (infection, allergy, etc) 3. Past history of allergy for tea 4. Unstable general condition 5. Joining other interventional studies

Design outcomes

Primary

Measure	Time frame
Safety, motor function, CK, oxidative stress marker (pre and post of each intervention phase)	—

Secondary

Measure	Time frame
cTnT, TGF-beta1, IL-6	—

Countries

Japan

Contacts

Public ContactYoshiko Tsuchie

National Hospital Organization Toneyama National Hospital Clinical research center

chiken@toneyama.go.jp06-6853-2001

Outcome results

None listed

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