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

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ClinicalTrials.gov Identifier: NCT02208414
Recruitment Status : Unknown
Verified August 2014 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serum crab- or shrimp-specific IgE [ Time Frame: before NAET, 1 month, 3 months and 6 months after NAET ]
  2. Skin test [ Time Frame: before NAET, 1 month and 6 months after NAET ]
    Skin test for crab or shrimp extract



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208414


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Cha Ze Lee, MD, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02208414    
Other Study ID Numbers: 201111069RID
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Keywords provided by National Taiwan University Hospital:
Food Allergies
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate