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| Name | Class |
|---|---|
| Zach Biotech Depot Sdn Bhd | UNKNOWN |
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This study has been designed as a randomized, double blinded, multi-centric, placebo controlled and phase II dose-ranging study. One group will receive placebo alone and the other three groups will receive IP twice daily (different dosages) for four months.
Labisia pumila or Kacip Fatimah, a native Malaysian plant, has been used as traditional medicine for over 400 years by both men and women for multiple treatments. Studies in animal models showed that Labisia pumila extract could regulate body weight gain and visceral fat reduction. SKF7® is a standardized extract of Labisia pumila (Kacip Fatimah) from the Myrsinaceae family.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKF7® - 375 mg | Experimental | Patients who meet the entry criteria for the study will be randomized to receive 375 mg SKF7® for 16 weeks |
|
| SKF7® - 562.5 mg | Experimental | Patients who meet the entry criteria for the study will be randomized to receive 562.5 mg SKF7® for 16 weeks |
|
| SKF7® - 750 mg | Experimental | Patients who meet the entry criteria for the study will be randomised to receive 750 mg SKF7® for 16 weeks |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKF7® Labisia pumila standardized extract | Other | Botanical extract of Labisia pumila (Kacip Fatimah) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving more than or equal to 5% weight loss OR | Percentage of patients achieving more than or equal to 5% weight loss for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo | Baseline Day 1 to Week 16 |
| Percentage of patients achieving more than or equal to 5 cm waist circumference reduction | Percentage of patients achieving more than or equal to 5 cm waist circumference reduction for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo | Baseline Day 1 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in body weight (kg) at week 16 | SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo | Baseline Day 1 to Week 16 |
| Percentage change from baseline in waist circumference (cm) at week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalini Vijayasingham, MBBS, MRCPS | Hospital Melaka, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Kesihatan Greentown | Ipoh | Malaysia | ||||
| Klinik Kesihatan Kuang |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37551550 | Derived | Swarna Nantha Y, Vijayasingham S, Adam NL, Vengadasalam P, Ismail M, Ali N, Chang LC, Ling LYL, Tee TT, Cheah YH. Labisia pumila standardized extract (SKF7(R)) reduces percentage of waist circumference and waist-to-height ratio in individuals with obesity. Diabetes Obes Metab. 2023 Nov;25(11):3298-3306. doi: 10.1111/dom.15229. Epub 2023 Aug 8. |
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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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|
SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
| Baseline Day 1 to Week 16 |
| Percentage change from baseline in waist to height ratio at week 16 | SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo | Baseline Day 1 to Week 16 |
| Percentage change from baseline in BMI at week 16 | SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo | Baseline Day 1 to Week 16 |
| Change in blood lipid concentrations. | The change in blood lipid concentrations (total cholesterol, triglyceride, HDL & LDL) | Baseline Day 1 to Week 16 |
| Incidence of AEs, SAEs and AEs leading to early discontinuation | Incidence of AEs, SAEs and AEs leading to early discontinuation | Up to Follow up visit Up to Week 17 |
| Kuang |
| Malaysia |
| Hospital Melaka | Malacca | Malaysia |
| Klinik Kesihatan Masjid Tanah | Malacca | Malaysia |
| Hospital Tuanku Jaafar | Seremban | Malaysia |
| Klinik Kesihatan Seremban 2 | Seremban | Malaysia |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |