Randomized Controlled Trial of Silymarin in Asthma
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|ClinicalTrials.gov Identifier: NCT01049178|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 14, 2010
Last Update Posted : February 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atopic Asthma||Drug: Oral Silymarin Drug: Oral Silymarin, maintenance dose Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Antioxidant Enzyme Induction as a New Approach to Therapy in Patients With Asthma|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Oral silymarin dose
Dose escalation study
Drug: Oral Silymarin
Dose Level 1: 1 capsules (1 cap at 140mg/cap) given three times per day for a total daily dose of 420 mg 28-days post Dose Level 1 Dose Level 2: 3 capsules (3 caps at 140mg/cap = 420 mg) given three times per day for a total daily dose of 1260 mg Day 56 (28-days post Dose Level 2) Dose Level 3: 5 capsules (5 caps at 140mg/cap = 700 mg) given three times per day for a total daily dose of 2100 mg Day 84 (28-days post Dose Level 3) We will evaluate change from baseline at each dose to determine the minimum effective dose.
Drug: Oral Silymarin, maintenance dose
The maintenance Silymarin dose will be selected based on the dose escalation study and will be dosed PO three times daily as recommended. Silymarin will be provided as a capsule S. marianum (70-80% silymarin), along with an identical appearance placebo capsule created by our investigational pharmacyAt each visit a questionnaire regarding daily symptoms and disease control, the asthma control test (ACT) will be completed, eNO measured, urine collected, spirometry (lung function) measured, venipuncture performed for blood collection (20 mL), as well as assessment of acceptability, toxicity, and masking.
Placebo Comparator: placebo
A randomized, double-masked, placebo-controlled cross-over clinical pilot investigation of an inducer of endogenous antioxidant enzymes, silymarin, in humans with atopic asthma.
- Exhaled nitric oxide (eNO), an indirect measure of airway inflammation that correlates with clinical asthma measures. [ Time Frame: 20-40 weeks ]
- Spirometry, disease control, urinary isoprostanes, antioxidant enzyme concentrations, silybin concentrations, acceptability, ability to maintain blinding, effect size for secondary clinical outcomes. [ Time Frame: 20-40 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049178
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2650|
|Principal Investigator:||Tina V. Hartert, MD, MPH||Vanderbilt University Medical Center|