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NCT00843544 · ClinicalTrials.gov registry record · Phase 2
Integrative Medicine Approach to the Management of Asthma in Adults
A Phase 2 study, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
NCT00843544 is a Phase 2 study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 156 participants.
The verdict
NCT00843544, a Phase 2 study, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
Study Summary
The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures. Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows: 1. Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using. 2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice 3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a
Interventions
- BEHAVIORAL Integrative Medicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00843544
The ClinicalTrials.gov registry entry for NCT00843544 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Integrative Medicine is the first listed.
NCT00843544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00843544 about?
NCT00843544 is a clinical study titled "Integrative Medicine Approach to the Management of Asthma in Adults". The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether a...
What is the current status of trial NCT00843544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2006-03. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00843544?
The interventions under investigation include: Integrative Medicine (BEHAVIORAL).
Who is sponsoring clinical trial NCT00843544?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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