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Intervention Group for Asthma

Phase 2
Waitlist Available
Led By Eric Arrata, ND
Research Sponsored by Canadian Institute of Natural and Integrative Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to safeguard against the possibility of excessive adverse events related to the tapering procedures or the orthomolecular treatment, an interim analysis will be conducted after 50% accrual is reached in this pilot investigation.
Awards & highlights

Study Summary

The purpose of this study is To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma; To obtain a preliminary estimate of the effectiveness of an orthomolecular treatment regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic children. The obtained estimate will allow sample size calculations for a full-scale randomized trial; and To obtain preliminary information about the safety and tolerability of an orthomolecular treatment regime.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~see primary endpoint
This trial's timeline: 3 weeks for screening, Varies for treatment, and see primary endpoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The last tolerated dose of inhaled corticosteroids will be the primary end point.
Secondary outcome measures
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Canadian Institute of Natural and Integrative MedicineLead Sponsor
2 Previous Clinical Trials
108 Total Patients Enrolled
Alberta Children's HospitalOTHER
53 Previous Clinical Trials
39,937 Total Patients Enrolled
1 Trials studying Asthma
818 Patients Enrolled for Asthma
Alberta Health servicesOTHER
157 Previous Clinical Trials
649,454 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Orthomolecular Therapy and Asthma in Children
2011. "Orthomolecular Therapy and Asthma in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00672529.
~6 spots leftby Apr 2025
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