Effect of Curcumin on Lung Inflammation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Effect of Curcumin on Lung Inflammation|
- Change in sputum dysplasia [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Number of subjects with adverse events in each arm of the study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
The study involves active arm of Curcumin+Bioprine
The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.
|Placebo Comparator: Placebo||Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514266
|United States, Texas|
|VA Medical Center|
|Houston, Texas, United States, 77030|