A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients
Overview
- Phase
- Phase 2
- Intervention
- Euiiyin-tang
- Conditions
- Obesity
- Sponsor
- Kyunghee University Medical Center
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Weight reduction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a superior reduction compared to those taking the placebo.
Detailed Description
This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm. They will be screened at first visit. At the baseline, that is the second visit, they will be evaluated each outcomes including weight, waist circumference, lipid profile (total cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes, etc.
Investigators
Seong-Gyu Ko
Professor
Kyunghee University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Women aged 18-65 years old
- •Patients applying to one of the followings 2.
- •BMI 30kg/m2 or over 2.
- •BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.
- •BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose \< 7.8mmol/L(140mg/dL) 2.
- •BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.
- •BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening
- •Agreed to low-calorie diet during the trial
- •Written informed consent of the trial
Exclusion Criteria
- •Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
- •Heart disease (heart failure, angina pectoris, myocardial infarction)
- •Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg)
- •Malignant tumour or lung disease
- •Cholelithiasis
- •Severe renal disability (SCr \> 2.0 mg/dL)
- •Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], alkaline phosphatase)
- •Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
- •Narrow angle glaucoma
- •History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
Arms & Interventions
Euiiyin-tang
powder type, 3 times per day before the meal, 12 weeks total
Intervention: Euiiyin-tang
Placebo
powder type, 3 times per day before the meal, 12 weeks total
Intervention: Placebo
Outcomes
Primary Outcomes
Weight reduction
Time Frame: between baseline and 12 weeks
Secondary Outcomes
- Total cholesterol(baseline and 12 weeks)
- Korean Obesity-related Quality of Life scale(baseline and 12 weeks)
- Triglyceride(baseline and 12 weeks)
- Subcutaneous fat area(baseline and 12 weeks)
- Blood glucose(baseline and 12 weeks)
- Waist/hip ratio(4 weeks, 8 weeks, and 12 weeks)
- Waist circumference(baseline, 4 weeks, 8 weeks, and 12 weeks)
- C-reactive protein (CRP)(baseline and 12 weeks)
- Visceral fat area(baseline and 12 weeks)
- Blood pressure(baseline, 4 weeks, 8 weeks, and 12 weeks)
- Korean version of Eating Attitudes Test-26(baseline and 12 weeks)