Borage Oil and Ginkgo Biloba (EGb 761) in Asthma

NCT00029679 | Completed Phase 1

• 1 other identifier: R01AT000637-02
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess clinical efficacy and/or adverse effects of dietary borage oil (which contains gamma-linolenic acid \[GLA\]) and Ginkgo biloba in patients with mild persistent to moderate asthma.

Conditions

Asthma

Interventions

Gingko biloba DRUG

Borage oil DRUG

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms (cough, wheeze, chest tightness) consistent with the National Asthma Education Program (NAEP) guidelines for mild persistent to moderate asthma

You may not qualify if:

• Severe asthma or mild intermittent asthma by NAEP revised guidelines
• History of vasovagal reactions (nausea, dizziness, flushed/warm) upon having blood drawn
• Pregnancy or lactation
• History of emergency room care in the last 6 months
• History of hospitalization
• Use of prednisone in the past 3 months
• Concurrent pulmonary disease: pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease
• Cigarette smoking within the past 1 year; over 10-pack year history of cigarette smoking in ex-smokers
• Recent (within one month) upper or lower respiratory tract infection
• The following concurrent medical diagnoses: alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, or a psychiatric disorder that is judged to make full participation difficult
• Use of prednisone in the past 3 months; current use of zileuton (leukotriene receptor antagonists are allowed) or theophylline
• Use of dietary supplements (except for standard dose multiple vitamins such as One-a-day or Centrum) including herbal supplements, mega dose of multiple vitamins/antioxidants, magnesium, fish oil, borage oil, evening primrose oil, black currant oil, fungal oil, G. biloba, quercetin, or mega intake of garlic or onion (subjects will be asked to stop such therapies as a requirement of enrollment)
• Ongoing use of homeopathic remedies or acupuncture, acupressure, therapeutic massage (subjects will be asked to stop such therapies as a requirement of enrollment)

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Ginkgo Extract; borage oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2002
• First Posted: January 21, 2002
• Study Start: September 1, 2000
• Study Completion: July 1, 2005
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)