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

August 3, 2014 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Procedure: NAET
NAET with acupressure and/or chiropractic procedures with the participant holding water vial
Placebo Comparator: Placebo
Treated with water vial
Procedure: NAET
NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial
Procedure: NAET
NAET with acupressure and/or chiropractic procedures with the participant holding water vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in allergic symptoms at 6 months
Time Frame: 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.
before NAET and 6 months after NAET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum crab- or shrimp-specific IgE
Time Frame: before NAET, 1 month, 3 months and 6 months after NAET
before NAET, 1 month, 3 months and 6 months after NAET
Skin test
Time Frame: before NAET, 1 month and 6 months after NAET
Skin test for crab or shrimp extract
before NAET, 1 month and 6 months after NAET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

August 3, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 3, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201111069RID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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