Randomized Controlled Trial of Silymarin in Asthma

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if intake of the antioxidant enzyme inducer, silymarin, will improve lung function and symptom scores in participants with asthma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Antioxidants; Silymarin

Criteria

Inclusion Criteria:

• Inclusion Criteria Male or female subject with confirmed asthma, AND

• Age ≥ 18 years

• Asthma Control Test (ACT) Score of 15-20, AND

• Documented atopy by prick skin testing (most study participants will likely have participated in one of the investigators prior observational studies and will have had skin testing, if not, this will be performed at an in-person screening visit), AND

• For women: Not pregnant, as determined by a negative urinary pregnancy test at the initial visit(visit 1), AND at the start of the cross-over period (visit 4), AND using birth control

Exclusion Criteria:

• Known allergies to plants in the Asteraceae family (thistles, daisies, artichokes, kiwi)

• Non-asthmatic, or inadequate documentation which includes lack of signs and symptoms of asthma, or lack of prior confirmatory testing

• Pregnant

• Age < 18 years

• Non-English speaking

• Current smoker (current, or within last year)

• Chronic Obstructive Pulmonary Disease(COPD)

• Unable to swallow capsules

• Unable to obtain informed consent

• Unable to comply with avoidance of honey and propolis containing foods (which interfere with the silybin assays for measurement of plasma concentrations)