- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724099
Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity
June 13, 2018 updated by: Seong-Gyu Ko, Kyunghee University Medical Center
A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients
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.
Study Overview
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
Enrollment (Actual)
149
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Incheon, Korea, Republic of, 405-760
- Gachon University Gil Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 18-65 years old
- 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
- 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.)
- History of stroke or temporary ischemic cardioplegia
- History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
- 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)
- Use of β--blocker or diuretic as hypertension medication within last 3 months
- Use of medication for central nervous system or central active weight reduction medication
- Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
- Difficult to measure anthropometric dimensions because of anatomical change such as resection
- Surgical history for weight reduction; bariatric surgery, etc.
- Unable to follow instructions of the trial as judged by investigator
- 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.)
- Use of other investigational product within last 1 month
- Reduction over 10% of the previous weight within 6 months
- Decided to stop smoking within last 3 months; however, keeping irregular smoking habit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Euiiyin-tang
powder type, 3 times per day before the meal, 12 weeks total
|
Korean medicinal herbal drug
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Placebo Comparator: Placebo
powder type, 3 times per day before the meal, 12 weeks total
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Placebo drug, same odor and formula as Euiiyin-tang
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight reduction
Time Frame: between baseline and 12 weeks
|
between baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein (CRP)
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
|
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Blood pressure
Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks
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baseline, 4 weeks, 8 weeks, and 12 weeks
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|
Blood glucose
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
|
|
Waist/hip ratio
Time Frame: 4 weeks, 8 weeks, and 12 weeks
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4 weeks, 8 weeks, and 12 weeks
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Waist circumference
Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks
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baseline, 4 weeks, 8 weeks, and 12 weeks
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|
Korean Obesity-related Quality of Life scale
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
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Korean version of Eating Attitudes Test-26
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
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Total cholesterol
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
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Triglyceride
Time Frame: baseline and 12 weeks
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baseline and 12 weeks
|
|
Visceral fat area
Time Frame: baseline and 12 weeks
|
Using abdominal computed tomography
|
baseline and 12 weeks
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Subcutaneous fat area
Time Frame: baseline and 12 weeks
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Using abdominal computed tomography
|
baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yoon-kyung SONG, KMD, Gachon University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cheon C, Song YK, Ko SG. Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial. Complement Ther Med. 2020 Jun;51:102423. doi: 10.1016/j.ctim.2020.102423. Epub 2020 May 21.
- Cheon C, Jang S, Park JS, Ko Y, Kim DS, Lee BH, Song HJ, Song YK, Jang BH, Shin YC, Ko SG. Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial. Trials. 2017 Jun 21;18(1):289. doi: 10.1186/s13063-017-2039-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
November 2, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 9, 2012
Study Record Updates
Last Update Posted (Actual)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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