Effects of Green Tea Extract (GTE) on Systemic Oxidative and Antioxidative Status in Chinese Patients With Stable Asthma
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|ClinicalTrials.gov Identifier: NCT01187147|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : August 23, 2010
Asthma is a disease characterized by chronic inflammation in the airways. Recent research has demonstrated that one of the reasons for the chronic inflammatory state is an imbalance between oxidative stress and antioxidative defenses in patients with asthma.
Green tea is a common beverage consumed by Chinese patients from all walks of life. Green tea contains chemical components that are thought to have immunomodulatory actions in chronic inflammation.
The investigators propose to recruit 35 patients with stable asthma. Recruited subject will be given oral tablets containing Green tea extract (GTE) to be taken daily for three months. Clinical follow up and assessment will be done at baseline, on completion of GTE intake at three months, and at three months after GTE intake has been stopped. A questionnaire on their health status and the frequency of symptoms and use of bronchodilators and inhaled steroids will be completed, spirometry will be done and a venous blood sample will be taken during recruitment and during each reassessment at 3 and 6 months. Measurement of oxidants/antioxidants (GSH, GSSG, SOD, CAT and GPx) will be carried out on the blood samples. Oxidants/antioxidants will be compared and correlated with lung function results.
This study would provide us with pilot data as to whether GTE, a strong antioxidant with immunomodulatory actions, has any effect on reducing the oxidative stress and improving the antioxidant status in patients with asthma and whether these changes are accompanied improvement in clinical status.
Hypothesis Green tea extract (GTE) reduces oxidative stress and improves antioxidant defenses in Chinese patients with asthma
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Dietary Supplement: green tea extract||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Green Tea Extract (GTE) on Systemic Oxidative and Antioxidative Status in Chinese Patients With Stable Asthma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Experimental: Green Tea
Recruited subjects will be asked to take green tea capsules for 3 months and then stopped for another 3 months.
Dietary Supplement: green tea extract
Green tea extract capsule, equivalent to 450 ml 2% Green tea containing 540mg EGCG/day
Other Name: Lung Chen green tea
- Serum Inflammatory markers [ Time Frame: Six months ]Serum catalase, superoxide dismutase, glutathione peroxidase, oxidized glutathione and other inflammatory markers including CRP, IL6 and IL8
- Respiratory symptoms [ Time Frame: Six months ]Respiratory symptoms
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187147
|University of Hong Kong Queen Mary Hospital|
|Hong Kong, Hong Kong, 0|
|Principal Investigator:||David CL Lam, MBBS,PhD,FCCP,FACP,FRCP(E)||The University of Hong Kong|