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An Autism Study Using Nambudripad's Food Allergy Elimination Treatments

Primary Purpose

Autism, Food Allergies

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupressure treatments and NAET treatments
Sponsored by
Nambudripad's Allergy Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, eye contact, Noncommunicable

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. - Exclusion Criteria: 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. -

Sites / Locations

  • PNIB Research Center

Outcomes

Primary Outcome Measures

Improvement in speech and communication

Secondary Outcome Measures

Elimination or reduction of commonly seen autistic traits

Full Information

First Posted
October 31, 2005
Last Updated
June 25, 2008
Sponsor
Nambudripad's Allergy Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00247156
Brief Title
An Autism Study Using Nambudripad's Food Allergy Elimination Treatments
Official Title
An Investigation Into the Effectiveness of NAET on Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nambudripad's Allergy Research Foundation

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Food Allergies
Keywords
Autism, eye contact, Noncommunicable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupressure treatments and NAET treatments
Primary Outcome Measure Information:
Title
Improvement in speech and communication
Secondary Outcome Measure Information:
Title
Elimination or reduction of commonly seen autistic traits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. - Exclusion Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi S. Nambudripad, LAc, PhD
Organizational Affiliation
The journal of NAET Energetics and Complementary Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
PNIB Research Center
City
Buena Park
State/Province
California
ZIP/Postal Code
90621
Country
United States

12. IPD Sharing Statement

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An Autism Study Using Nambudripad's Food Allergy Elimination Treatments

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