Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02208414

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Food Allergies	Procedure: NAET Procedure: NAET	N/A

Detailed Description

Nambudripad allergy elimination techniques (NAET) were developed by Dr. Devi Nambudripad in 1983. Many patients have been relieved of allergy and allergy-related disease by this treatment.

Lack of well-controlled clinical study prevents NAET from being accepted as a treatment option in current medical system.

The aim of this project is to conduct a double blind-placebo controlled study of applying NAET to treat crab or shrimp allergy.

The parameters to be measured are allergic symptom, crab- or shrimp-specific IgE and skin test before and after NAET treatment

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized Double-Blind Placebo-Controlled Crab Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques in NTU Campus

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crab or shrimp Intervention: treated with crab and shrimp energy signature vial using NAET	Procedure: NAET NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial
Placebo Comparator: Placebo Treated with water vial	Procedure: NAET NAET with acupressure and/or chiropractic procedures with the participant holding water vial

Arm

Intervention/Treatment

Experimental: Crab or shrimp

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

Procedure: NAET

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

Placebo Comparator: Placebo

Treated with water vial

Procedure: NAET

NAET with acupressure and/or chiropractic procedures with the participant holding water vial

Outcome Measures

Primary Outcome Measures

Change from Baseline in allergic symptoms at 6 months [before NAET and 6 months after NAET]
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.

Secondary Outcome Measures

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]
Skin test for crab or shrimp extract

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Cha Ze Lee, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT02208414

Other Study ID Numbers:

201111069RID

First Posted:

Aug 5, 2014

Last Update Posted:

Aug 5, 2014

Last Verified:

Aug 1, 2014

Keywords provided by National Taiwan University Hospital

Food Allergies

Additional relevant MeSH terms:

Hypersensitivity

Food Hypersensitivity

Study Results

No Results Posted as of Aug 5, 2014