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Milk AllergyPhase 1/2NCT00328731

Milk ALLERGY ELIMINATION THROUGH NAET® (Nambudripad's Allergy Elimination Techniques).

A Phase 1/2 study testing Procedure in people with Milk Allergy, run by Nambudripad's Allergy Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 78 yearsHealthy volunteers can take part
Conditions the study is for
Milk Allergy
What is being tested?
Procedure
Type of treatment
Surgery or procedure
How many people
26 participants
Where
1 siteUnited States
Study dates
Jan 2005to Jan 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Known milk allergy, sensitivity or intolerances. -

Who cannot join

  • No milk allergy or sensitivity H/o Anaphylaxis or severe reactions Any other major illnesses preventing from taking part in any study
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NAET-Pain Clinic

    Buena Park, California, 90621

Other trials in United States

About this study

Official title: The Effectiveness of Milk Allergy Elimination Through NAET Treatments

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.

Read the 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:

  1. NAET®/Experimental group, and
  2. 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.

Conditions
Milk Allergy
Being tested
Procedure
Keywords
Allergy, NAET
Medical subject headings
Milk Hypersensitivity, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProcedureProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of Milk allergies

Secondary outcomes (1)
  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2006 (estimated)
  2. Study startJan 2005
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
26 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00328731
Sponsor's protocol ID
NAR Foundation study 120
Status last verified
Jan 2005
First submitted
19 May 2006
Last updated
22 May 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Procedure in people with Milk Allergy, run by Nambudripad's Allergy Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of Milk allergies. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2006.

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