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| Name | Class |
|---|---|
| Medika Natura Sdn Bhd | INDUSTRY |
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This study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7â„¢).
Labisia pumila or Kacip Fatimah is a native Malaysian and Indonesian plant. It has been used as traditional medicine for over 400 years by both men and women for multiple treatments including toning and firming the abdominal area. As a water-ethanol dry extract, it has been reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood glucose and sex hormones. In Malaysia, this Kacip Fatimah extract has been used as a natural anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the trade-name of Labeesity® or SKF7™. This extract has been shown to be pesticide / herbicide free and has branded halal ingredient identity and security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (dosage A) | Experimental | The lower dose of the active drug |
|
| Group B (dosage 2) | Experimental | The middle dose of the active drug |
|
| Group C (dosage 3) | Experimental | The higher dose of the active drug |
|
| Group D (placebo) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose | Drug | Dosage 1 |
| |
| Middle-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Percentage of subjects whose Body Weight is lowered | 12 weeks |
| Change in waist and hip circumferences | Change in waist and hip circumference | 12 weeks |
| Change in the waist-hip and waist-height ratios | Change in waist-hip ratio and waist-height ratio | 12 weeks |
| Change in Body Mass Index (BMI) | Change in BMI in kg/m^2 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat percentage | The change of body fat percentage | 12 weeks |
| Lean Body Mass | The amount of lean body mass will be calculated from body fat percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal vital signs and of abnormal laboratory test results | Abnormality of vital signs and laboratory test results | 12 weeks |
| Incidence of Adverse Events | The incidence and percentage of Adverse events and serious adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arini Setiawati, PhD | Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia | Study Chair |
| Nafrialdi Agus, MD, PhD | Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indonesia Medical Education and Research Institute | Jakarta | DKI Jakarta | 10430 | Indonesia | ||
| Faculty of Medicine, Krida Wacana Christian University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30235727 | Result | Lee S, Lee H, Cho Y, Kim J, Kang JW, Seo BK, Baek YH, Lee JD. The efficacy and safety of Hanslim for obese patients: Study protocol for a multicenter, randomized, double-blind, multi-dose, placebo-controlled, phase IIb clinical trial. Medicine (Baltimore). 2018 Sep;97(38):e12440. doi: 10.1097/MD.0000000000012440. |
| Label | URL |
|---|---|
| EMA Guideline on clinical evaluation of medicinal products used in weight control | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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4 parallel groups, 3 doses of study drug versus placebo
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Active drug and placebo are made in similar
| Drug |
Dosage 2 |
|
| Higher-dose | Drug | Dosage 3 |
|
| Placebo | Drug | Placebo |
|
| 12 weeks |
| 12 weeks |
| Jakarta |
| DKI Jakarta |
| 11510 |
| Indonesia |
| Makara Satellite Clinic | Depok | West Java | 16424 | Indonesia |
| The Asia-Pacific Perspective: Redefining Obesity and its Treatment | View source |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |