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Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

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ClinicalTrials.gov Identifier: NCT01724099
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Euiiyin-tang Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : April 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2017

Arm Intervention/treatment
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




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

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

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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724099


Locations
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Kyunghee University Medical Center
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Investigators
Principal Investigator: Yoon-kyung SONG, KMD Gachon University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01724099     History of Changes
Other Study ID Numbers: HP001
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by Seong-Gyu Ko, Kyunghee University Medical Center:
Obesity
Herbal product
Korean Medicine

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms