Metabolic Syndrome, Obesity
Conditions
Keywords
metabolic syndrome, Daesiho-tang, Taeeumjowi-tang, Korean medicine
Brief summary
The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors
Interventions
DRUGDaesiho-tang
Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
DRUGChowiseungcheng-tang
Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.
DRUGPlacebo
Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Sponsors
Sangji University Oriental Medical Hospital, Korea
DongGuk University
Gachon University Gil Oriental Medical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female aged 18 to 65 years * Subject must included at least one or more of the following symptoms below * BMI of 30 kg/㎡ or more; * BMI between 25 and 29.9kg/㎡ with hypertension, taking medication or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit * BMI between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose \> 126mg/dL at the screening visit * BMI between 25 and 29.9kg/㎡ with hyperlipidemia, taking medication or total cholesterol ≥ 200mg/dL or Triglyceride ≥ 150mg/dL at screening visit * Agreed to low-calorie diet during the trial * Written informed consent of the trial
Exclusion criteria
* Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc. * Heart disease (heart failure, angina pectoris, myocardial infarction) * 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) * History of narrow angle glaucoma * History of stroke or temporary ischemic cardioplegia * History of eating disorder such as anorexia nervosa or bulimia nervosa, etc. * Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion) * Use of CNS stimulant medication for weight loss * Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse) * history of weight loss surgery, such as bariatric surgery, etc. * Subjects who are judged to be inappropriate for the clinical study by the researchers * Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) * Use of other investigational product within last 1 month * 10 percent reduction in body weight over 6 months * Decided to quit smoking over the last 3 months or have irregular smoking habits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in body weight | baseline, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in fat mass | baseline, 4,8,12,16 weeks |
| Changes from baseline in Waist circumference | baseline, 4,8,12,16 weeks |
| Changes from baseline in Waist/hip ratio | baseline, 4,8,12,16 weeks |
| Changes from baseline in Body mass index | baseline, 4,8,12,16 weeks |
| Changes from baseline in Lipid profile | Screening visit, 12 weeks |
| Changes from baseline in body fat percentage | baseline, 4,8,12,16 weeks |
| Changes from baseline in blood glucose | Screening visit, 12 weeks |
| Changes from baseline in abdominal visceral fat area | baseline, 12 weeks |
| Korean Obesity-related Quality of Life (QoL) scale | baseline, 12 weeks |
| Korean version of Eating Attitudes Test-26 | baseline, 12 weeks |
| Changes from baseline in C-reactive protein (CRP) | Screening visit, 12 weeks |
Countries
South Korea
Outcome results
None listed