Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques
Primary Purpose
Food Allergies
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NAET
NAET
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergies focused on measuring Food Allergies
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Crab or shrimp
Placebo
Arm Description
Intervention: treated with crab and shrimp energy signature vial using NAET
Treated with water vial
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Serum crab- or shrimp-specific IgE
Skin test
Skin test for crab or shrimp extract
Full Information
NCT ID
NCT02208414
First Posted
January 2, 2013
Last Updated
August 3, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02208414
Brief Title
Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques
Official Title
A Randomized Double-Blind Placebo-Controlled Crab Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques in NTU Campus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergies
Keywords
Food Allergies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crab or shrimp
Arm Type
Experimental
Arm Description
Intervention: treated with crab and shrimp energy signature vial using NAET
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treated with water vial
Intervention Type
Procedure
Intervention Name(s)
NAET
Intervention Description
NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial
Intervention Type
Procedure
Intervention Name(s)
NAET
Intervention Description
NAET with acupressure and/or chiropractic procedures with the participant holding water vial
Primary Outcome Measure Information:
Title
Change from Baseline in allergic symptoms at 6 months
Description
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.
Time Frame
before NAET and 6 months after NAET
Secondary Outcome Measure Information:
Title
Serum crab- or shrimp-specific IgE
Time Frame
before NAET, 1 month, 3 months and 6 months after NAET
Title
Skin test
Description
Skin test for crab or shrimp extract
Time Frame
before NAET, 1 month and 6 months after NAET
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cha Ze Lee, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques
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