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Effect of Curcumin on Lung Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514266
First Posted: January 23, 2012
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Amir Sharafkhaneh, Baylor College of Medicine
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Drug: Curcumin+Bioprine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Curcumin on Lung Inflammation

Further study details as provided by Amir Sharafkhaneh, Baylor College of Medicine:

Primary Outcome Measures:
  • Change in sputum dysplasia [ Time Frame: 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:
  • Number of subjects with adverse events in each arm of the study. [ Time Frame: 3 months ]

Enrollment: 57
Study Start Date: April 2005
Study Completion Date: August 2010
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curcumin+bioprine
The study involves active arm of Curcumin+Bioprine
Drug: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01514266


Locations
United States, Texas
VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
  More Information

Responsible Party: Amir Sharafkhaneh, Associate Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01514266     History of Changes
Other Study ID Numbers: H-17419
First Submitted: January 12, 2012
First Posted: January 23, 2012
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by Amir Sharafkhaneh, Baylor College of Medicine:
proven diagnosis
COPD
sputum

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Respiratory Tract Diseases
Pathologic Processes
Respiratory Tract Infections
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action