Clinical trial NCT01724099: Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity
Official title: A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity
Herbal product
Korean Medicine
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: Gachon University Gil Medical Center
First posted: 2012-11-09
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Weight reduction
timeFrame: between baseline and 12 weeks
Secondary outcomes:
measure: C-reactive protein (CRP)
timeFrame: baseline and 12 weeks
measure: Blood pressure
timeFrame: baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Blood glucose
timeFrame: baseline and 12 weeks
measure: Waist/hip ratio
timeFrame: 4 weeks, 8 weeks, and 12 weeks
measure: Waist circumference
timeFrame: baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Korean Obesity-related Quality of Life scale
timeFrame: baseline and 12 weeks
measure: Korean version of Eating Attitudes Test-26
timeFrame: baseline and 12 weeks
measure: Total cholesterol
timeFrame: baseline and 12 weeks
measure: Triglyceride
timeFrame: baseline and 12 weeks
measure: Visceral fat area
timeFrame: baseline and 12 weeks
measure: Subcutaneous fat area
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Medical Center
name: Yoon-kyung SONG, KMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.