Integrative Medicine Approach to the Management of Asthma in Adults

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843544
• Other study ID #: 170-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 12, 2009
• Last updated: February 12, 2009
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2009
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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: 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.

Locations

Country	Name	City	State
United States	Beth Israel Medical Center/Center for Health and Healing	NY	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Quality of Life Questionnaire		Baseline, 6 weeks, 3 months, 6 months	No
Secondary	Medical Outcomes Study Short Form-12 (SF-12)		Baseline, 6 weeks, 3 months, 6 months	Yes