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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02147041 |
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Date of registration:
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20/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides
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Scientific title:
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The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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92 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT02147041 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chung-Hua Hsu, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Taipei medical hospital, Linsen Chinese Medicine branch |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged between 20 and 60 years old women
- Chinese
- body mass index (BMI) > 27 kg/m2
- waist circumference (WC) > 80 cm
- willing to participate in and fill out the questionnaires for this trial.
Exclusion Criteria:
- GPT > 80 U/L, serum creatinine > 2.0 mg/dl
- breast feeding or pregnancy
- heart failure
- acute myocardial infarction
- Stroke
- any other conditions not suitable for trial as evaluated by the physician
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hyperlipidemia
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Diabetes Mellitus
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Intervention(s)
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Drug: EGCG(Epigallocatechin Gallate)
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Drug: Placebo
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Primary Outcome(s)
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composite of anthropometric measures
[Time Frame: compare between the beginning of the study and after 12 weeks of treatment.]
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Secondary Outcome(s)
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Hormone peptide change
[Time Frame: compared between the beginning of the study and after 12 weeks of treatment]
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traditional chinese medicine syndrome classification
[Time Frame: compare between the beginning of the study and after 12 weeks of treatment.]
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biochemical characteristic change
[Time Frame: compare between the beginning of the study and after 12 weeks of treatment.]
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Quality of life evaluation
[Time Frame: compare between the beginning of the study and after 12 weeks of treatment.]
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Secondary ID(s)
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100XDAA00110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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