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Completed

NCT Number: NCT00843544

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 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beth Israel Medical Center/Center for Health and Healing

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy or lactation
  • Concurrent serious or life-threatening illness as determined by clinical judgment
  • Psychiatric disorder as determined by clinical judgment.
  • Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
  • Fish allergy or history of adverse reaction to vitamin C or fish oil as determined by clinical history.

Treatment and study plan

Integrative Medicine

Behavioral

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:

  • 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.
  • Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
  • 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.

Primary outcomes

  1. Asthma Quality of Life Questionnaire

    Time frame: Baseline, 6 weeks, 3 months, 6 months

Secondary outcomes

  1. Medical Outcomes Study Short Form-12 (SF-12)

    Time frame: Baseline, 6 weeks, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2009
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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