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Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Kyunghee University Medical Center
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center Identifier:
First received: November 2, 2012
Last updated: June 22, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Drug: Euiiyin-tang
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: between baseline and 12 weeks ]

Secondary Outcome Measures:
  • C-reactive protein (CRP) [ Time Frame: baseline and 12 weeks ]
  • Blood pressure [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks ]
  • Blood glucose [ Time Frame: baseline and 12 weeks ]
  • Waist/hip ratio [ Time Frame: 4 weeks, 8 weeks, and 12 weeks ]
  • Waist circumference [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks ]
  • Korean Obesity-related Quality of Life scale [ Time Frame: baseline and 12 weeks ]
  • Korean version of Eating Attitudes Test-26 [ Time Frame: baseline and 12 weeks ]
  • Total cholesterol [ Time Frame: baseline and 12 weeks ]
  • Triglyceride [ Time Frame: baseline and 12 weeks ]
  • Visceral fat area [ Time Frame: baseline and 12 weeks ]
    Using abdominal computed tomography

  • Subcutaneous fat area [ Time Frame: baseline and 12 weeks ]
    Using abdominal computed tomography

Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Euiiyin-tang
powder type, 3 times per day before the meal, 12 weeks total
Drug: Euiiyin-tang
Korean medicinal herbal drug
Placebo Comparator: Placebo
powder type, 3 times per day before the meal, 12 weeks total
Drug: Placebo
Placebo drug, same odor and formula as Euiiyin-tang

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women aged 18-65 years old
  2. Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8mmol/L(140mg/dL) 2.4. BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening
  3. Agreed to low-calorie diet during the trial
  4. Written informed consent of the trial

Exclusion Criteria:

  1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
  2. Heart disease (heart failure, angina pectoris, myocardial infarction)
  3. Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg)
  4. Malignant tumour or lung disease
  5. Cholelithiasis
  6. Severe renal disability (SCr > 2.0 mg/dL)
  7. Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
  8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
  9. Narrow angle glaucoma
  10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
  11. History of stroke or temporary ischemic cardioplegia
  12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
  13. Use of medication that could have effect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having effect on absorption, metabolism, excretion)
  14. Use of β--blocker or diuretic as hypertension medication within last 3 months
  15. Use of medication for central nervous system or central active weight reduction medication
  16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  17. Difficult to measure anthropometric dimensions because of anatomical change such as resection
  18. Surgical history for weight reduction; bariatric surgery, etc.
  19. Unable to follow instructions of the trial as judged by investigator
  20. Women who were pregnant, lactating, planning a pregnancy or women of childbearing age who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.)
  21. Use of other investigational product within last 1 month
  22. Reduction over 10% of the previous weight within 6 months
  23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit
  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 identifier: NCT01724099

Contact: Seong-gyu KO, KMD 82-2-961-9278

Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Yoon-kyung SONG, Doctor    070-7120-5046   
Principal Investigator: Yoon-kyung SONG, KMD         
Sponsors and Collaborators
Kyunghee University Medical Center
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Principal Investigator: Yoon-kyung SONG, KMD Gachon University Medical Center
  More Information

Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center Identifier: NCT01724099     History of Changes
Other Study ID Numbers: HP001 
Study First Received: November 2, 2012
Last Updated: June 22, 2016

Keywords provided by Kyunghee University Medical Center:
Herbal product
Korean Medicine

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on February 23, 2017