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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

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE August 5, 2014
Last Update Posted Date August 5, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2014)
  • Serum crab- or shrimp-specific IgE [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques
Official Title  ICMJE A Randomized Double-Blind Placebo-Controlled Crab Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques in NTU Campus
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Food Allergies
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Crab or shrimp
    Intervention: treated with crab and shrimp energy signature vial using NAET
    Intervention: Procedure: NAET
  • Placebo Comparator: Placebo
    Treated with water vial
    Intervention: Procedure: NAET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 3, 2014)
80
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02208414
Other Study ID Numbers  ICMJE 201111069RID
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cha Ze Lee, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP