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Phase I clinical safety study of Enzyme-treated Asparagus Extract (ETAS) by the healthy subjects (a randomized placebo-controlled trial)

Phase I clinical safety study of Enzyme-treated Asparagus Extract (ETAS) by the healthy subjects (a randomized placebo-controlled trial) - The phase I safety study of Enzyme-treated Asparagus Extract (ETAS)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016582
Enrollment
50
Registered
2015-04-01
Start date
2015-04-01
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

Healthy Volunteer

Interventions

Group A(ETAS capsule) Group B(placebo capsule)

Sponsors

Osaka University Graduate School of Medicine, Department of Integrative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The subjects who are not the patients without drug treatments 2) Possible to orally supprementation. 4) the age is over 20 years old 3) Satisfy the following items of pre-screening exams. - Leukocyte counts: > 3,000 /mm3 and < 12,000 /mm3 - Platelet conuts: > 100,000 /mm3 - HbA1c: <6.5 (JDS) or <6.9 (NGSP) - Serum AST and ALT: under 2.5 times of the criterion in this hospital - Serum creatinin: < 2.5 mg/dL - e-GFR (MDRD): > 30 ml/min/1.73 m2 5) the subjects who signed consent form

Exclusion criteria

Exclusion criteria: 1) Severe clinical history 2) Pregnancy or the subjects to desire it. 3) Lactation period 4) The subject who cannot measure the body composition by bioelectrical impedance analysis because of equipment of medical machine such as pacemaker or severe dry skin. 5) The case that the doctor judged to be unsuitable for the participation of this examination

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
The clinical efficacy (blood cortisol and Heat Shock Protein 70(HSP70) expression level)

Countries

Japan

Contacts

Public ContactAsuka Yasueda

Osaka University Graduate School of Medicine Department of Integrative Medicine

a-yasueda@cam.med.osaka-u.ac.jp+81668793498

Outcome results

None listed

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