The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to examine the therapeutic effect of green tea extract on obese women and the correlation analysis between traditional Chinese medicine syndrome and obese related hormone peptides.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

NCT00383058

Obesity

COMPLETED PHASE3

Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex

NCT06609603

Body Fat

RECRUITING NA

The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea

NCT06295822

Chinese Medicine Primary Dysmenorrhea

RECRUITING NA

Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

NCT05072990

Type 2 Diabetes Mellitus in Obese Dyslipidemia Associated With Type II Diabetes Mellitus

COMPLETED

Development of Active Safety Surveillance System for Traditional Chinese Medicine

NCT00275964

Climacteric Symptoms Hot Flushes and/or Sweats

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGCG(Epigallocatechin Gallate)

EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)

Group Type EXPERIMENTAL

EGCG(Epigallocatechin Gallate)

Intervention Type DRUG

500mg, three times a day, duration:12 weeks

placebo

cellulose (500mg, three times a day, 12 weeks)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EGCG(Epigallocatechin Gallate)

500mg, three times a day, duration:12 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EGCG-Epigallocatechin Gallate, green tea extract cellulose-cellulose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No