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.
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.
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:
- 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.
- 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.
Reduction of Milk allergies
Secondary outcomes (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.
- First posted22 May 2006 (estimated)
- Study startJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Nambudripad's Allergy Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Devi S Nambudripad, DC,PhD,L.Ac, Principal investigator, NAR Foundation
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Milk Allergy Elimination Through NAET Treatments
- ClinicalTrials.gov ID
- NCT00328731
- Acronym / sponsor ID
- NAR Foundation study 120
- Conditions
- Milk Allergy
- Keywords
- Allergy, NAET
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- Nambudripad's Allergy Research FoundationUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jan 2006
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Known milk allergy, sensitivity or intolerances. -
Key exclusion criteria (2 listed)
- No milk allergy or sensitivity H/o Anaphylaxis or severe reactions Any other major illnesses preventing from taking part in any study
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure | Procedure or surgery | – |
Primary outcome
Reduction of Milk allergies
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2006.
- NAR Foundation is a Nonprofit Research FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devi S Nambudripad, DC,PhD,L.Ac principal investigator
NAR Foundation
1 site in 1 country: see every site and its status.
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.