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Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients

NCT01221350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-11-08

Study results available
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Summary

The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to improve the quality of life of patients with asthma.

The investigators will administrate 600 mg lipoic acid orally on a daily basis during two months concurrent with the patient anti-asthmatic therapy and evaluate the effects on resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related quality of life previous to the initial of the treatment and at 60 days of the supplementary therapy.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lipoic acid

Lipoic acid 600 mg dose (two 300 mg capsules) once daily in the morning. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed.

DIETARY_SUPPLEMENT

Placebo

Placebo (two capsules filled with 300 mg vehicle) once daily in the morning during 60 days. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • University of Guadalajara

    collaborator OTHER

  • Hospital Civil Juan I. Menchaca

    collaborator OTHER

  • Centro Universitario de Ciencias de la Salud, Mexico

    lead OTHER

Principal Investigators

  • Fernando R. Siller Lopez, PhD · Centro Universitario de Ciencias de la Salud, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221350 on ClinicalTrials.gov