Effect of Curcumin on Lung Inflammation

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Curcumin+Bioprine; Drug: Placebo

• Registration Number: NCT01514266
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.

Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-05
• Study Completion: 2010-08
• Status Verified: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-20
• Last Update Submitted: 2012-01-20
• Study First Posted: 2012-01-23
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
• 20 pack year cigarette smoking
• Stable clinical course (symptoms/ medications) for 8 weeks
• Fixed address/Not planning to leave
• Being able to perform spirometry
• Able to understand and consent

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Exclusion Criteria

• Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis
• Heart failure NYH III & IV; symptomatic liver or renal failure
• Dementia or other neurocognitive deficit preventing completion of symptom diary
• Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin+bioprine	Curcumin+Bioprine	The study involves active arm of Curcumin+Bioprine
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in sputum dysplasia	3 months	We evaluated presence of moderate or worse dysplasia at baseline and each subsequent visits. The primary endpoint of this study is change in sputum cytological abnormality (moderate or worse dysplasia). The change will be comparison of 3-month follow up compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events in each arm of the study.	3 months

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 Houston, Texas, United States