Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
1. Generic drug name : Taeeumjowui-tang
2. The dosage given, the method and frequency of administration : total 30 grams daily, orally administered. (3 times daily, 2 packs at a time.
Sponsors
Cheonan Oriental Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 19 and 64. 2. Diagnosed by SCAT (Sasang Constitutional Analysis Tool) as a Taeum type person (Taeum-in). 3. BMI of 23 or more 4. Meet the criteria of waist circumference, and one or more other metabolic syndrome criteria. 5. Blood pressure, diabetes, and hyperlipidemia are controlled stably so do not need additional medical prescriptions. 6. Able to communicate with researchers and are able to follow the test compliance.
Exclusion criteria
Exclusion criteria: 1. Meet the following criteria 1.1. HbA1c 8.5% or more 1.2. Fasting triglyceride : TG = 400 1.3. LDL-chol. = 190 1.4. Blood pressure =160/100mmHg 2. History of severe renal impairment (renal failure, nephrotic syndrome, glomerular disease), dialysis history, or Cr level more than twice the normal upper limit. 3. History of severe liver disease (cirrhosis, liver cancer), or AST or ALT greater than 2.5 times the normal level. 4. Acute phase or urgent angina pectoris, myocardial infarction, stroke, cardiac or cerebrovascular disease. 5. Gastrointestinal problems(anorexia, nausea, vomiting, etc.) unlikely to be able to participate under the researcher’s judgement. 6. Those who have participated in other interventional clinical trials within the last 3 months. 7) Artificial weight loss of more than 10% of the total weight within 6 weeks. 8) Those with neuropsychiatric disorders. 9) Those with excessive alcohol consumption (more than 14 bottles per week) 10) Allergic to test drug ingredients 11) Those who plan to participate in other clinical trials during the course of this trial. 12) Currently taking medication for hyperthyroidism, or TSH level more than 1.5 times the normal upper limit. 13. Diagnosed with malignant tumor or received chemotherapy within 5 years. 14. Those who have taken the following medications within 3 months: 14.1. Ephedrine 14.2. MAO inhibitors 14.3. Thyroid medications (thyroxine, lyothionine) 14.4. Catecholamines (epinephrine, isoprenaline) 14.5. Xanthines (theophylline, dipropyline). 15. Changes in medical prescriptions for blood pressure, diabetes, hyperlipidemia, obesity within 3 months. 16. Other serious medical conditions or symptoms unlikely to be able to participate under the researcher’s judgement. 17. Hidrosis 18. Excessive weakness, or in the aftermath of a disease. 19. Severe urinary disorders 20. Genetic problems such has galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 21. Those who are expected to have dietary changes during the clinical trial 22. Pregnant or the possibility of pregnancy, or nursing mother. 23. Those who have a history of elevated blood glucose by taking ephedrine 24. Those who have taken drugs that can affect body weight such as appetite suppressants, laxatives (without prescription) or oral steroids, thyroid hormones, amphetamines, ciproheptadine, phenodiazines, or drugs that affect absorption or metabolism within 3 months. 25. Those who have undergone surgical surgery for weight loss such as gastroplasty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI) will be measured at baseline (visit 2) and 12 weeks later (visit 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in the number of metabolic syndrome risk factors according to the metabolic syndrome criteria (NCEP-ATPIII, 2006 Defining Abdominal Obesity in the Korean Population, Korean Society for the Study of Obesity). Metabolic syndrome is diagnosed when three or more of the following criteria are met. 1.1. Waist circumberence: men = 90 cm, women = 85 cm. 1.2. High fasting glucose: = 100 mg/dL 1.3. Hypertriglyceridemia: = 150 mg/dL 1.4. Low HDL-chol. : men <40 mg/dL , women <50 mg/dL 1.5. High blood pressure: = 130/85 mmHg 2. Dyslipidemia will be determined using changes in triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol at baseline, 4 weeks, 8 weeks, and 12 weeks. 3. Changes in blood pressure will be determined by measuring blood pressure (SBP, DBP) at baseline, 4 weeks, 8 weeks, and 12 weeks. 4. Blood sugar will be measured using: 4.1. Changes in FBS (IFG), insulin NS free fatty acid at baseline, 4 weeks, 8 weeks, and 12 weeks. 4.2. Changes in HbA1c at baseline, 8 weeks, and 12 weeks. 5. Obesity factors will be measured using: 5.1. Changes in BMI at baseline, 4 weeks, and 8 weeks. 5.2. Changes in waist circumference at baseline, 4 weeks, 8 weeks, and 12 weeks. 6. Collecting oriental medical information: 6.1. Facial color measurement, voice measurement, body measurement, and questionnaire at visit 5. 6.2. 3D facial measurement at visit 1 and 5. 6.3. Tongue diagnosis, body temperature (Digital Infrared Thermal Imaging) measurement at visit 2 and 5. 7. The changes in glucose metabolism and metabolic syndrome risk factors will be measured using the oral glucose tolerance test (OGTT) on 30 subjects whose fasting blood glucose level is 110 mg/dl or more, and who | — |
Countries
Korea, South
Contacts
Public ContactTaek-Won Ahn
Outcome results
None listed