Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-29 @ 8:34 PM
Study NCT ID:
NCT00247156
Status:
COMPLETED
Last Update Posted:
2008-06-26
First Post:
2005-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Autism Study Using Nambudripad's Food Allergy Elimination Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2008-06-25', 'studyFirstSubmitDate': '2005-10-31', 'studyFirstSubmitQcDate': '2005-10-31', 'lastUpdatePostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in speech and communication'}], 'secondaryOutcomes': [{'measure': 'Elimination or reduction of commonly seen autistic traits'}]}, 'conditionsModule': {'keywords': ['Autism', 'eye contact', 'Noncommunicable'], 'conditions': ['Autism', 'Food Allergies']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "An autism Pilot Study Using NAET (Nambudripad's Allergy Elimination Techniques)\n\nAim/Question:\n\nThe 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.\n\nTo 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.\n\nWhen 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.\n\nThe complete NAET program usually takes about 75-100 office visits over a span of couple of years.\n\nMethod:\n\nThe 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).\n\nNARF IRB Approval:\n\nAfter 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).\n\nNAET ALLERGENS TO TREAT AUTISM\n\n1. Egg Mix\n2. Calcium mix\n3. Vitamin C\n4. B complex vitamins\n5. Sugar Mix\n6. Iron Mix\n7. Vitamin A\n8. Mineral Mix\n9. Heavy Metals\n10. Salt Mix\n11. Corn Mix\n12. Grain Mix\n13. Artificial Sweeteners\n14. Yeast Mix\n15. Stomach acid\n16. Digestive enzymes\n17. Neurotransmitters\n18. Immunizations and Vaccinations: either you received or your parent received before you were born. Test them individually and if found treat them individually.\n\n (MMR: (measles, mumps, rubella), DPT: (diphtheria, pertussis, tetanus), Polio vaccine, Small pox, Chickenpox, Influenza, hepatitis-B, hepatitis C.)\n19. Pesticides\n20. Alcohol\n21. Coffee Mix\n22. Nut Mix 1\n23. Nut Mix 2\n24. Spice Mix 1\n25. Spice Mix 2\n26. Animal Fats\n27. Vegetable Fats\n28. Vitamin F (\n29. Dried Bean Mix\n30. Amino Acids-1\n31. Amino Acids 2\n32. Dimethyl Glycine\n33. Food additives\n34. Food colors\n35. Night-shade vegetables\n36. Starch Complex\n37. Drugs with allergy: Antibiotics (Individual antibiotics)\n38. Hormones\n39. Baking powder/ Baking soda\n40. School work materials\n41. Fabrics\n42. Water\n43. Chemicals\n44. Plastics\n45. Hypothalamus\n46. Brain Tissue\n47. Parts of the Brain\n48. Other enzymes\n49. Perfume mix\n50. Tobacco smoke"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nVolunteers 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. -\n\nExclusion Criteria:\n\nAny 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.\n\n1. Previous surgeries, congenital deformities of heart, lung, liver, brain, kidney, etc.\n2. Any type of cancer\n3. Aids\n4. Any physically debilitating disorders and diagnosed mental retardation, Down's syndrome, etc.\n5. Children with the history of severe allergies or anaphylactic reactions will be rejected.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT00247156', 'briefTitle': "An Autism Study Using Nambudripad's Food Allergy Elimination Treatments", 'organization': {'class': 'OTHER', 'fullName': "Nambudripad's Allergy Research Foundation"}, 'officialTitle': 'An Investigation Into the Effectiveness of NAET on Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': 'narfoundationautismstudy'}, 'secondaryIdInfos': [{'id': 'narffoundation 101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Acupressure treatments and NAET treatments', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90621', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'PNIB Research Center', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}], 'overallOfficials': [{'name': 'Devi S. Nambudripad, LAc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The journal of NAET Energetics and Complementary Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nambudripad's Allergy Research Foundation", 'class': 'OTHER'}}}}