Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Green Tea Extract (GTE) on Systemic Oxidative and Antioxidative Status in Chinese Patients With Stable Asthma

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01187147
First received: August 20, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention
Asthma
Dietary Supplement: green tea extract

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Green Tea Extract (GTE) on Systemic Oxidative and Antioxidative Status in Chinese Patients With Stable Asthma

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Serum Inflammatory markers [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Serum catalase, superoxide dismutase, glutathione peroxidase, oxidized glutathione and other inflammatory markers including CRP, IL6 and IL8


Secondary Outcome Measures:
  • Respiratory symptoms [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Respiratory symptoms


Enrollment: 30
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma patients being followed up in out-patient clinic with stable clinical condition.
  • Age 18 - 70 years

Exclusion Criteria:

  • Patients with known significant concomitant illness including pulmonary causes (COPD, pulmonary tuberculosis, lung cancer, bronchiectasis, interstitial lung disease and obstructive sleep apnoea) and non-pulmonary causes (hypertension, diabetes mellitus, ischaemic heart disease, stroke, cancer of other organ sites).
  • Patients with unstable asthma
  • Patients with alcohol dependence
  • Patients with abnormal liver function or is a hepatitis B or C carrier,
  • Patients who have habits of taking tea or tea extract, or under other clinical drug trial or herbs
  • Patients who are pregnant or breast feeding
  • Patients who are unwilling to participate or unable to give written consent on his/her own
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187147

Locations
Hong Kong
University of Hong Kong Queen Mary Hospital
Hong Kong, Hong Kong, 0
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: David CL Lam, MBBS,PhD,FCCP,FACP,FRCP(E) The University of Hong Kong
  More Information

No publications provided

Responsible Party: David CL Lam, University of Hong Kong
ClinicalTrials.gov Identifier: NCT01187147     History of Changes
Other Study ID Numbers: HKCTR415
Study First Received: August 20, 2010
Last Updated: August 20, 2010
Health Authority: Hong Kong:University of Hong Kong

Keywords provided by The University of Hong Kong:
Asthma, green tea, antioxidants

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014