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A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization

A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization - A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020794
Enrollment
100
Registered
2016-02-01
Start date
2015-10-01
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

Atopic disease

Interventions

propolis From entry to blood sampling at 1 year, participants are asked to take propolis (302.4mg/day) for 2 to 10 months. placebo From entry to blood sampling at 1 year, participants are asked to t

Sponsors

The Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Mother has atopic symptom; having or had at least one of asthma, atopic dermatitis, food allergy, allergic rhinitis or hay fever in medical inquiry. Not only medical judgment by physician, personal statement is also acceptable. 2) Breast feeding. Combination with artificial milk is also acceptable. 3) Infant is 2-8 month-old; exceptionally if the infant has been suffering before 8 months-old, entry is available till 10 month-old. 4) Infant has dermatitis (eczema, dry skin, etc.). It continuously or intermittently exists more than 1 month although intensive skin care such as soap at bath time is conducted on him/her without any medical anti-inflammatory treatment on local skin. If there is medical intervention, symptom less than 1 month is acceptable.

Exclusion criteria

Exclusion criteria: 1) Mother is under 20 year-old. 2) Infant has significant primary disease other than atopic disease. 3) Mother has allergy against; Wheat, propolis, honey, perilla oil,farina, geratin, glycerin, pectine, carrageenan, beeswax or lectin (from soybean) 4) Totally artificial milk feeding.

Design outcomes

Primary

MeasureTime frame
Non-specific IgE is more than 10 IU/mL or antigen-specific IgE is more than 0.34 IU/mL in an infant when 1 year-old.

Secondary

MeasureTime frame
1) Atopic asthma bronchitis: Symptom of wheezing at medical inquiry and IgE against mites more than 0.34 IU/mL 2) Atopic dermatitis: Prescription of topical steroid during taking supplements

Countries

Japan

Contacts

Public ContactGen Igarashi

The Jikei University School of Medicine Molecular Epidemiology

gengeniga@gmail.com03-3433-1111

Outcome results

None listed

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