NCT02208414

Brief Summary

Purpose of this study is to determine whether NAET procedures are effective in the treatment of crab or shrimp allergy. Hypothesis: experimental group will show a significant improvement over the control group in allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp extract.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

January 2, 2013

Last Update Submit

August 3, 2014

Conditions

Food Allergies

Keywords

Food Allergies

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in allergic symptoms at 6 months

    Symptoms when exposed to crab or shrimp which include symptoms of skin, eye, respiratory tract, gastrointestinal tract, cardiovascular system and others. The participants give score subjectively from 0 to 10 according to the severity of the symptoms.

    before NAET and 6 months after NAET

Secondary Outcomes (2)

  • Serum crab- or shrimp-specific IgE

    before NAET, 1 month, 3 months and 6 months after NAET

  • Skin test

    before NAET, 1 month and 6 months after NAET

Study Arms (2)

Crab or shrimp

EXPERIMENTAL

Intervention: treated with crab and shrimp energy signature vial using NAET

Procedure: NAET

Placebo

PLACEBO COMPARATOR

Treated with water vial

Procedure: NAET

Interventions

NAETPROCEDURE

NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial

Crab or shrimp

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older or equal to 20 years old
  • History of allergic to crab or shrimp
  • Positive serum crab- or shrimp-specific IgE

You may not qualify if:

  • History of anaphylactic shock
  • On medication of anti-histamine or steroid
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Cha Ze Lee, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

August 5, 2014

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

TW(1)