AutismPhase 1/2NCT00247156
An Autism Study Using Nambudripad's Food Allergy Elimination Treatments
A Phase 1/2 study testing Acupressure treatments and NAET treatments in people with Autism and Food Allergies, run by Nambudripad's Allergy Research Foundation at 1 site in United States.
Trial summary
1. We hypothesize that children in the experimental group will show a significant improvement over the control group as all food allergens groups and some other relevant allergenic substances are desensitized in a systematic way using the NAET® methodology within the specified period of study. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism, Food Allergies
- What is being tested?
- Acupressure treatments and NAET treatments
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2005
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteers will be selected based on the well-defined inclusion criteria such as all control and sample children showed typical autistic symptoms before NAET® treatment: made no eye contact, unable to talk and communicate. All subjects (both control and sample) should be within the age limit of 3 to10 years and should have established and demonstrated autism spectrum disorder by a conventional physician. -
Who cannot join
- Any child that has a history of various complications of illness other than autism spectrum disorder would be disqualified. Previously treated with NAET treatments for this condition will be disqualified to enroll in the study. Any patient who has any of the following incidents will also be disqualified.
- Previous surgeries, congenital deformities of heart, lung, liver, brain, kidney, etc.
- Any type of cancer
- Aids
- Any physically debilitating disorders and diagnosed mental retardation, Down's syndrome, etc.
- Children with the history of severe allergies or anaphylactic reactions will be rejected.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation Into the Effectiveness of NAET on Autism Spectrum Disorders
- We hypothesize that children in the experimental group will show a significant improvement over the control group as all food allergens groups and some other relevant allergenic substances are desensitized in a systematic way using the NAET® methodology within the specified period of study.
Read the detailed description
An autism Pilot Study Using NAET (Nambudripad's Allergy Elimination Techniques)
Aim/Question:
The principle goal of this proposed study (pilot study) is to test the efficacy of NAET® (Nambudripad's Allergy Elimination Technique) protocols for the treatment of Autism Spectrum Disorder in children between the ages of 3-10 years old, especially in the areas of improving language and communication skills.
To elaborate further, the NAET® protocols uses chiropractic/acupuncture manipulation of spinal nerve roots to alert the nervous system about the presence of the allergen in the hand and thus to wake up the dormant sensory nerve fibers (the sympathetic and parasympathetic nerve fibers) that carry messages from the periphery to the association cortex of the brain, through spinal nerves of the body, as well as from the brain to the periphery and target organs (also known as afferent and efferent nerves). This is followed by acupressure massage on specific acupuncture points to balance the energy of the entire nervous system. Avoidance of the treated allergen/substance for 24 hours after treatment completes the NAET® treatment protocol.
When we enroll them into NAET program, most of them are nonverbal and non-communicable. But by the time they complete 10 to 15 NAET basic treatments for an allergy to essential nutrients, most of them start verbal and nonverbal communications, social interactions, playing with other children, improve sleep, reduce restlessness, reduce irritability, reduce abnormal body movements like flapping hands, pulling hair, etc., and start behaving like normal children. When they finish the complete NAET program most of them become normal again.
The complete NAET program usually takes about 75-100 office visits over a span of couple of years.
Method:
The NAET® method has been highlighted in literature (Nambudripad DS: Say Goodbye to Illness, Third Edition, Delta Pub 1999, 136-137; Nambudripad DS: Say Good-bye to Allergy-related Autism. Delta Pub 2001; The Journal of NAET Energetics and complementary medicine 1 (1) 76-79, 2005, The Journal of NAET Energetics and complementary medicine 1 (1) 85-86, 2005, Tsering: Natural Health 29 (6) 80-85, 1999, and and Teuber and Porch-Curren: Curr Opin Allergy Clin Immunol 3:217-221, 2003).
NARF IRB Approval:
After the design and conceptualization of this clinical project, a summary of the project was submitted to the Nambudripad's Allergy Research Foundation Institutional Review Board. The NARF IRB will study the project and would meet to discuss the pros and cons of this project. There will be external physicians whose specialization would include pediatrics and child welfare to evaluate the project and the ethical treatment to children. (The board after asking several questions approved this study unanimously in October 2004. The Board also requested for periodic (every six months) updates on the progress of this project).
NAET ALLERGENS TO TREAT AUTISM
- Egg Mix
- Calcium mix
- Vitamin C
- B complex vitamins
- Sugar Mix
- Iron Mix
- Vitamin A
- Mineral Mix
- Heavy Metals
- Salt Mix
- Corn Mix
- Grain Mix
- Artificial Sweeteners
- Yeast Mix
- Stomach acid
- Digestive enzymes
- Neurotransmitters
- Immunizations and Vaccinations: either you received or your parent received before you were born. Test them individually and if found treat them individually. (MMR: (measles, mumps, rubella), DPT: (diphtheria, pertussis, tetanus), Polio vaccine, Small pox, Chickenpox, Influenza, hepatitis-B, hepatitis C.)
- Pesticides
- Alcohol
- Coffee Mix
- Nut Mix 1
- Nut Mix 2
- Spice Mix 1
- Spice Mix 2
- Animal Fats
- Vegetable Fats
- Vitamin F (
- Dried Bean Mix
- Amino Acids-1
- Amino Acids 2
- Dimethyl Glycine
- Food additives
- Food colors
- Night-shade vegetables
- Starch Complex
- Drugs with allergy: Antibiotics (Individual antibiotics)
- Hormones
- Baking powder/ Baking soda
- School work materials
- Fabrics
- Water
- Chemicals
- Plastics
- Hypothalamus
- Brain Tissue
- Parts of the Brain
- Other enzymes
- Perfume mix
- Tobacco smoke
- Conditions
- Autism, Food Allergies
- Being tested
- Acupressure treatments and NAET treatments
- Keywords
- Autism, eye contact, Noncommunicable
- Medical subject headings
- Autistic Disorder, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure treatments and NAET treatmentsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in speech and communication
Secondary outcomes (1)
Elimination or reduction of commonly seen autistic traits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Nambudripad's Allergy Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Devi S. Nambudripad, LAc, PhD, Principal investigator, The journal of NAET Energetics and Complementary Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247156
- Sponsor's protocol ID
- narfoundationautismstudy
- Other IDs
- narffoundation 101
- Status last verified
- Apr 2006
- First submitted
- 31 Oct 2005
- Last updated
- 26 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effectiveness of NAET on Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00247156
- Acronym / sponsor ID
- narfoundationautismstudy
- Conditions
- Autism, Food Allergies
- Keywords
- Autism, eye contact, Noncommunicable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Nambudripad's Allergy Research FoundationUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Nov 2005
- First posted
- 1 Nov 2005 (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 hypothesize that children in the experimental group will show a significant improvement over the control group as all food allergens groups and some other relevant allergenic substances are desensitized in a systematic way using the NAET® methodology within the specified period of study.
Detailed description
An autism Pilot Study Using NAET (Nambudripad's Allergy Elimination Techniques)
Aim/Question:
The principle goal of this proposed study (pilot study) is to test the efficacy of NAET® (Nambudripad's Allergy Elimination Technique) protocols for the treatment of Autism Spectrum Disorder in children between the ages of 3-10 years old, especially in the areas of improving language and communication skills.
To elaborate further, the NAET® protocols uses chiropractic/acupuncture manipulation of spinal nerve roots to alert the nervous system about the presence of the allergen in the hand and thus to wake up the dormant sensory nerve fibers (the sympathetic and parasympathetic nerve fibers) that carry messages from the periphery to the association cortex of the brain, through spinal nerves of the body, as well as from the brain to the periphery and target organs (also known as afferent and efferent nerves). This is followed by acupressure massage on specific acupuncture points to balance the energy of the entire nervous system. Avoidance of the treated allergen/substance for 24 hours after treatment completes the NAET® treatment protocol.
When we enroll them into NAET program, most of them are nonverbal and non-communicable. But by the time they complete 10 to 15 NAET basic treatments for an allergy to essential nutrients, most of them start verbal and nonverbal communications, social interactions, playing with other children, improve sleep, reduce restlessness, reduce irritability, reduce abnormal body movements like flapping hands, pulling hair, etc., and start behaving like normal children. When they finish the complete NAET program most of them become normal again.
The complete NAET program usually takes about 75-100 office visits over a span of couple of years.
Method:
The NAET® method has been highlighted in literature (Nambudripad DS: Say Goodbye to Illness, Third Edition, Delta Pub 1999, 136-137; Nambudripad DS: Say Good-bye to Allergy-related Autism. Delta Pub 2001; The Journal of NAET Energetics and complementary medicine 1 (1) 76-79, 2005, The Journal of NAET Energetics and complementary medicine 1 (1) 85-86, 2005, Tsering: Natural Health 29 (6) 80-85, 1999, and and Teuber and Porch-Curren: Curr Opin Allergy Clin Immunol 3:217-221, 2003).
NARF IRB Approval:
After the design and conceptualization of this clinical project, a summary of the project was submitted to the Nambudripad's Allergy Research Foundation Institutional Review Board. The NARF IRB will study the project and would meet to discuss the pros and cons of this project. There will be external physicians whose specialization would include pediatrics and child welfare to evaluate the project and the ethical treatment to children. (The board after asking several questions approved this study unanimously in October 2004. The Board also requested for periodic (every six months) updates on the progress of this project).
NAET ALLERGENS TO TREAT AUTISM
- Egg Mix
- Calcium mix
- Vitamin C
- B complex vitamins
- Sugar Mix
- Iron Mix
- Vitamin A
- Mineral Mix
- Heavy Metals
- Salt Mix
- Corn Mix
- Grain Mix
- Artificial Sweeteners
- Yeast Mix
- Stomach acid
- Digestive enzymes
- Neurotransmitters
- Immunizations and Vaccinations: either you received or your parent received before you were born. Test them individually and if found treat them individually. (MMR: (measles, mumps, rubella), DPT: (diphtheria, pertussis, tetanus), Polio vaccine, Small pox, Chickenpox, Influenza, hepatitis-B, hepatitis C.)
- Pesticides
- Alcohol
- Coffee Mix
- Nut Mix 1
- Nut Mix 2
- Spice Mix 1
- Spice Mix 2
- Animal Fats
- Vegetable Fats
- Vitamin F (
- Dried Bean Mix
- Amino Acids-1
- Amino Acids 2
- Dimethyl Glycine
- Food additives
- Food colors
- Night-shade vegetables
- Starch Complex
- Drugs with allergy: Antibiotics (Individual antibiotics)
- Hormones
- Baking powder/ Baking soda
- School work materials
- Fabrics
- Water
- Chemicals
- Plastics
- Hypothalamus
- Brain Tissue
- Parts of the Brain
- Other enzymes
- Perfume mix
- Tobacco smoke
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Volunteers will be selected based on the well-defined inclusion criteria such as all control and sample children showed typical autistic symptoms before NAET® treatment: made no eye contact, unable to talk and communicate. All subjects (both control and sample) should be within the age limit of 3 to10 years and should have established and demonstrated autism spectrum disorder by a conventional physician. -
Key exclusion criteria (7 listed)
- Any child that has a history of various complications of illness other than autism spectrum disorder would be disqualified. Previously treated with NAET treatments for this condition will be disqualified to enroll in the study. Any patient who has any of the following incidents will also be disqualified.
- Previous surgeries, congenital deformities of heart, lung, liver, brain, kidney, etc.
- Any type of cancer
- Aids
- Any physically debilitating disorders and diagnosed mental retardation, Down's syndrome, etc.
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 |
|---|---|---|
| Acupressure treatments and NAET treatments | Procedure or surgery | – |
Primary outcome
Improvement in speech and communication
1 secondary outcome
Elimination or reduction of commonly seen autistic traits
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 26 Jun 2008.
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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, LAc, PhD principal investigator
The journal of NAET Energetics and Complementary Medicine
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 Acupressure treatments and NAET treatments in people with Autism and Food Allergies, 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 7 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 26 Jun 2008. 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?
Improvement in speech and communication. 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 26 Jun 2008.