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Integrative Medicine Approach to the Management of Asthma in Adults
This study has been completed.
First Received: February 12, 2009   No Changes Posted
Sponsor: Beth Israel Medical Center
Information provided by: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00843544
  Purpose

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 30-minute period about the most traumatic or stressful life experience to date.

Condition Intervention Phase
Asthma
 Behavioral: Integrative Medicine
 Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Asthma Dietary Supplements Diets
U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Asthma Quality of Life Questionnaire [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Integrative Medicine: Experimental Behavioral: Integrative Medicine

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 30-minute period about the most traumatic or stressful life experience to date.
Control: No Intervention

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80
  2. Class II through IV asthma sufferers will be included (mild persistent; moderate persistent; severe persistent).
  3. Ability to read and write at minimum fifth grade level
  4. Willing to comply with study instructions and sign an informed consent
  5. English-speaking

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Concurrent serious or life-threatening illness as determined by clinical judgment
  3. Psychiatric disorder as determined by clinical judgment.
  4. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
  5. Fish allergy or history of adverse reaction to vitamin C or fish oil as determined by clinical history.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843544

Locations
United States, New York
Beth Israel Medical Center/Center for Health and Healing
NY, New York, United States, 10016
Sponsors and Collaborators
Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center ( Benjamin Kligler )
Study ID Numbers: 170-05
Study First Received: February 12, 2009
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00843544     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
 Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010



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