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| Name | Class |
|---|---|
| Sangji University Oriental Medical Hospital, Korea | UNKNOWN |
| DongGuk University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daesiho-tang | Experimental | Dose: 6g, three times a day, each taken before or between meals for 12 weeks |
|
| Jowiseungcheung-tang | Experimental | Dose: 6g, three times a day, each taken before or between meals for 12 weeks |
|
| Placebo | Placebo Comparator | Dose: 6g, three times a day, each taken before or between meals for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daesiho-tang | Drug | Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body weight | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body fat percentage | baseline, 4,8,12,16 weeks | |
| Changes from baseline in fat mass | baseline, 4,8,12,16 weeks | |
| Changes from baseline in Waist circumference |
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Inclusion Criteria:
Female aged 18 to 65 years
Subject must included at least one or more of the following symptoms below
Agreed to low-calorie diet during the trial
Written informed consent of the trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun-Kyung Song, KMD | Gachon University Gil Oriental Medical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Oriental Medical Hospital | Incheon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32000419 | Derived | Kim HJ, Ko Y, Kim H, Cha YY, Jang BH, Song YK, Ko SG. A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors: Double blinded, randomized, multicenter, placebo controlled study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(5):e18955. doi: 10.1097/MD.0000000000018955. |
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| Chowiseungcheng-tang | Drug | Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd. |
|
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| Placebo | Drug | Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. |
|
| 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 C-reactive protein (CRP) | Screening visit, 12 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 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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