AllergyPhase 1/2NCT00292656
Importance of Hand Washing After Each NAET® Treatment
A Phase 1/2 study testing NAET in people with Allergy, run by Nambudripad's Allergy Research Foundation at 1 site in United States.
Trial summary
Background: It has been suspected in our clinic patients that when patients do not wash their hands after receiving NAET treatments, the effect of their treatments has been reduced or in some cases, the same treatment has to be repeated more times to be effective. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- NAET
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Allergy -
Who cannot join
- None
- -
Trial locations and contacts
1 site in 1 country.
About this study
Background: It has been suspected in our clinic patients that when patients do not wash their hands after receiving NAET treatments, the effect of their treatments has been reduced or in some cases, the same treatment has to be repeated more times to be effective.
Location of the study: PNIB Research Center 6714 Beach Blvd. Buena Park, CA 90621
Read more
Purpose The purpose of the study was to determine the importance of hand-washing with plain water after each NAET® treatment. The study utilized an experimental design with random assignment to two groups, consisting of treatment/experimental, and treatment/control groups.
Objective: We sought to determine if there is any benefit to mandate hand-washing with plain water after each NAET® treatment.
Read the detailed description
Selection of the Subjects:
The study was limited to the established patients in our clinic who came for NAET treatments on a Wednesday. Wednesday was chosen since it was a full working day and more patients will be treated on Wednesdays. First patient who arrived in the office was assigned into the experimental/treating group, then every odd number was selected as treating group. All even numbers were selected as placebo group..
Inclusion Criteria The primary inclusion criterion was that patients are getting treated for NAET on that day. All new patients were excluded. Only existing patients were chosen for this study. All the subjects included were required to sign a consent form, which allowed the researcher to designate them as subjects for the study.
Exclusion Criteria The exclusion criteria were: Serious illness, e.g., cancer, chronic obstructive pulmonary diseases, kidney diseases, heart diseases, pregnancy, mental diseases, and history of anaphylaxis.
Group Assignments:
38 females, and 22 males ages ranged between 12-60 years were randomly assigned to 2 groups:
- Experimental group: 30 (22 females and 8 males) subjects were assigned to this group.
- Control group: 30 (16 females and 14 males) subjects were assigned to this group.
Experimental Subjects:
They were advised to wash their hands with soap and water before beginning of NAET treatments. They were also asked to wash their hands with plain water (no soap) after completing NAET treatment before they left the office.
Control group:
They were advised not to wash their hands before or after the NAET treatment. They were allowed to go home soon after the treatment.
Evaluation Methods:
All subjects were treated for their appropriate scheduled allergens for that day. After the NAET, they waited for 20 minutes in the office. Then they were rechecked for the treated allergens. All of them had successfully completed their treatments. The experimental group was advised to wash their hands with plain water and they were advised to go home. The control group was advised to go home without washing their hands with water. They were asked to return on the following Wednesday for reexamination. A week after the treatment, they all returned for recheck and the resuls were recorded.
Duration of The Study The study duration was 7 days.
Results:
Experimental Group: 28 passed the treatment. 2 failed the treatment. Control Group: 5 passed the treatment. 25 failed the treatment. NAET Treatment was successful in 93.3% of the experimental group who utilized hand-washing after NAET treatment. NAET Treatment was successful 16.6% in the control group who did not wash their hands after NAET treatment.
Conclusion: The study concluded that hand-washing with plain water after each NAET treatment is essential for completing NAET treatments successfully.
Reprints Request from:
NAR Foundation 6714-32 Beach Blvd. Buena Park, CA 90621 narfoundation@yahoo.com
- Conditions
- Allergy
- Being tested
- NAET
- Keywords
- Allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAETProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
We sought to determine if there is any benefit to mandate hand-washing with plain water after each NAET® treatment.
Secondary outcomes (1)
Educational
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Nambudripad's Allergy Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Devi S. Nambudripad, DC,LAc.,PhD., Principal investigator, NAR Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292656
- Sponsor's protocol ID
- Hand washing After NAET
- Other IDs
- narfoundation study 119
- Status last verified
- Feb 2006
- First submitted
- 15 Feb 2006
- Last updated
- 4 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Hand Washing After Each NAET® Treatment
- ClinicalTrials.gov ID
- NCT00292656
- Acronym / sponsor ID
- Hand washing After NAET
- Conditions
- Allergy
- Keywords
- Allergy
- 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
- Dec 2005
- Study completion
- Dec 2005
- First posted
- 16 Feb 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.
Background: It has been suspected in our clinic patients that when patients do not wash their hands after receiving NAET treatments, the effect of their treatments has been reduced or in some cases, the same treatment has to be repeated more times to be effective.
Location of the study: PNIB Research Center 6714 Beach Blvd. Buena Park, CA 90621
Purpose The purpose of the study was to determine the importance of hand-washing with plain water after each NAET® treatment. The study utilized an experimental design with random assignment to two groups, consisting of treatment/experimental, and treatment/control groups.
Objective: We sought to determine if there is any benefit to mandate hand-washing with plain water after each NAET® treatment.
Detailed description
Selection of the Subjects:
The study was limited to the established patients in our clinic who came for NAET treatments on a Wednesday. Wednesday was chosen since it was a full working day and more patients will be treated on Wednesdays. First patient who arrived in the office was assigned into the experimental/treating group, then every odd number was selected as treating group. All even numbers were selected as placebo group..
Inclusion Criteria The primary inclusion criterion was that patients are getting treated for NAET on that day. All new patients were excluded. Only existing patients were chosen for this study. All the subjects included were required to sign a consent form, which allowed the researcher to designate them as subjects for the study.
Exclusion Criteria The exclusion criteria were: Serious illness, e.g., cancer, chronic obstructive pulmonary diseases, kidney diseases, heart diseases, pregnancy, mental diseases, and history of anaphylaxis.
Group Assignments:
38 females, and 22 males ages ranged between 12-60 years were randomly assigned to 2 groups:
- Experimental group: 30 (22 females and 8 males) subjects were assigned to this group.
- Control group: 30 (16 females and 14 males) subjects were assigned to this group.
Experimental Subjects:
They were advised to wash their hands with soap and water before beginning of NAET treatments. They were also asked to wash their hands with plain water (no soap) after completing NAET treatment before they left the office.
Control group:
They were advised not to wash their hands before or after the NAET treatment. They were allowed to go home soon after the treatment.
Evaluation Methods:
All subjects were treated for their appropriate scheduled allergens for that day. After the NAET, they waited for 20 minutes in the office. Then they were rechecked for the treated allergens. All of them had successfully completed their treatments. The experimental group was advised to wash their hands with plain water and they were advised to go home. The control group was advised to go home without washing their hands with water. They were asked to return on the following Wednesday for reexamination. A week after the treatment, they all returned for recheck and the resuls were recorded.
Duration of The Study The study duration was 7 days.
Results:
Experimental Group: 28 passed the treatment. 2 failed the treatment. Control Group: 5 passed the treatment. 25 failed the treatment. NAET Treatment was successful in 93.3% of the experimental group who utilized hand-washing after NAET treatment. NAET Treatment was successful 16.6% in the control group who did not wash their hands after NAET treatment.
Conclusion: The study concluded that hand-washing with plain water after each NAET treatment is essential for completing NAET treatments successfully.
Reprints Request from:
NAR Foundation 6714-32 Beach Blvd. Buena Park, CA 90621 narfoundation@yahoo.com
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Allergy -
Key exclusion criteria (2 listed)
- None
- -
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 |
|---|---|---|
| NAET | Procedure or surgery | – |
Primary outcome
We sought to determine if there is any benefit to mandate hand-washing with plain water after each NAET® treatment.
1 secondary outcome
Educational
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 4 Apr 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,LAc.,PhD. 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 NAET in people with 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 4 Apr 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?
We sought to determine if there is any benefit to mandate hand-washing with plain water after each NAET® treatment.. 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 4 Apr 2006.