Milk ALLERGY ELIMINATION THROUGH NAET® (Nambudripad's Allergy Elimination Techniques).
Primary Purpose
Milk Allergy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Milk Allergy focused on measuring Allergy, NAET
Eligibility Criteria
Inclusion Criteria: Known milk allergy, sensitivity or intolerances. - Exclusion Criteria: No milk allergy or sensitivity H/o Anaphylaxis or severe reactions Any other major illnesses preventing from taking part in any study -
Sites / Locations
- NAET-Pain Clinic
Outcomes
Primary Outcome Measures
Reduction of Milk allergies
Secondary Outcome Measures
This study also evaluated the reliability of performing two testing procedures (NST & PDRS) by two independent examiners in testing the subjects for milk at two different times.
Full Information
NCT ID
NCT00328731
First Posted
May 19, 2006
Last Updated
May 19, 2006
Sponsor
Nambudripad's Allergy Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00328731
Brief Title
Milk ALLERGY ELIMINATION THROUGH NAET® (Nambudripad's Allergy Elimination Techniques).
Official Title
The Effectiveness of Milk Allergy Elimination Through NAET Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Nambudripad's Allergy Research Foundation
4. Oversight
5. Study Description
Brief Summary
We sought to determine the efficacy of NAET® in permanently eliminating milk allergy for a sample of patients.
We hypothesize that the subjects in the experimental group will show similar level of allergies and sensitivities initially on all nine diagnostic measures used here. After receiving the NAET treatments, the Experimental group will demonstrate a significant reduction in the milk sensitivities and allergies when compared to the control group at the final evaluation using same diagnostic measures.
Detailed Description
Background: Although several standard clinical techniques are used to detect and treat common allergic conditions, each one is limited in scope and requires to follow repeated treatment protocols. The non-invasive system known as NAET® does not generally have such limitations and has over the last twenty-three years been demonstrated to be effective clinically in thousands of cases. NAET® is a natural treatment that utilizes standard medical diagnostic measures along with kinesiolgocal, chiropractic and oriental testing, procedures to identify the allergens, as well as the intensity of reactions to the allergens which vary from individual to individual. Treatment consists of a sequence of spinal manipulations at specific thoracic and lumbar spinal levels along with acupuncture acupressure on configurations of standard acupuncture points.
Methods: In a double blind study, 26 patients with diagnosed milk allergy (13 males, 13 females, age range between 18-65 years) were randomly assigned to 2 groups:
NAET®/Experimental group, and
Placebo/control group The study was conducted by 12 volunteer-clinicians from NAET Research associates, divided into six investigator groups. Each group conducted a designated sequential part of the study independently from all other groups, that is, was blinded from all other groups for the duration of the study. Subjects from both groups (Experimental and Control) were evaluated immediatedly before treatment and eight weeks thereafter using the following nine diagnostic measures: Subjective history (Allergy Symptom Rating Scale or ASRS); ALCAT Test; antibodies to milk protein in the blood serum by Immunoglobulins G, Immunoglobulins A, Immuno-globulins M, and Immunoglobulins E (IgG, IgA, IgM, IgE) by Elisa method (enzyme linked Immunozorbant Assay); Intradermal testing for milk sensitivity. NSTRS (Kinesiological muscle response testing also known as Neuromuscular Sensitivity Testing) and Pulse difference Rating Scale (PDRS) were tested by two well trained NST clinicians at two different times before and after the treatments. Both groups demonstrated allergic sensitivities to whole milk test sample in varying degrees. After completing the evaluations, the Experimental group received 2 NAET® treatments on whole milk, on two consecutive Saturdays. The Placebo group received two treatments on placebo samples on the same days along with the experimental group on two consecutive Saturdays as well. At the end of the treatment phase, once again both groups were evaluated for whole milk test sample using all of the nine diagnostic measures.
Results On the nine diagnostic measures there was a significant difference in the means of the before and after measures of the Experimental group, while they remained almost the same for the Placebo group. At 95% CI, p-values were less than 0.05 in all tests except for IgG study (p-value=1.30). NSTRS and PDRS were evaluated by two clinicians at different time to evaluate the intertester relability among two clinicians for these two tests. A significant correlation was noticed with the results both testers received on these two testing-NST and PDRS (p-value <0.0001).
Conclusion The study demonstrated the efficacy of eliminating or reducing milk allergy using the NAET® treatment protocol. This study also evaluated the reliability of performing two testing procedures (NST & PDRS) by two independent examiners in testing the subjects for milk at two different times. There was a significant correlation in the results they received as shown above, when the two clinicians tested the subjects independently, demonstrating that there is a good reliability between these well trained clinicians in their performance while doing these two evaluations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Allergy
Keywords
Allergy, NAET
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
26 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Procedure
Primary Outcome Measure Information:
Title
Reduction of Milk allergies
Secondary Outcome Measure Information:
Title
This study also evaluated the reliability of performing two testing procedures (NST & PDRS) by two independent examiners in testing the subjects for milk at two different times.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Known milk allergy, sensitivity or intolerances. -
Exclusion Criteria:
No milk allergy or sensitivity H/o Anaphylaxis or severe reactions Any other major illnesses preventing from taking part in any study
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi S Nambudripad, DC,PhD,L.Ac
Organizational Affiliation
NAR Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
NAET-Pain Clinic
City
Buena park
State/Province
California
ZIP/Postal Code
90621
Country
United States
12. IPD Sharing Statement
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Milk ALLERGY ELIMINATION THROUGH NAET® (Nambudripad's Allergy Elimination Techniques).
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