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

Food Allergies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02208414
• Other study ID #: 201111069RID
• Status: Active, not recruiting
• Phase: N/A
• First received: January 2, 2013
• Last updated: August 3, 2014
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Allergies
• Food Hypersensitivity
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before NAET and 6 months after NAET	No
Secondary	Serum crab- or shrimp-specific IgE		before NAET, 1 month, 3 months and 6 months after NAET	No
Secondary	Skin test	Skin test for crab or shrimp extract	before NAET, 1 month and 6 months after NAET	No