NCT01724099

Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Euiiyin-tang	Korean medicinal herbal drug
DRUG	Placebo	Placebo drug, same odor and formula as Euiiyin-tang

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-02-01
• Completion: 2017-06-01
• First posted: 2012-11-09
• Last updated: 2018-06-15

Locations

1 site across 1 country: South Korea