Dose-ranging Study of SKF7™ for Obesity

Study Overview
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Brief Summary
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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 (SKF7™).

Detailed Description
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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.

Official Title
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Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study

Conditions
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Obesity

Intervention / Treatment
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* Drug: low-dose
* Drug: Middle-dose
* Drug: Higher-dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity Willing to participate in the study by signing the informed consent Healthy by anamnesis Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period. Exclusion Criteria: Positive result for Rapid test for COVID-19 at screening period. Known hypersensitivity to any herbal product. Pregnant or lactating women. Taking any other weight loss therapy and/or lipid lowering products. Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 parallel groups, 3 doses of study drug versus placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (dosage A)<br>The lower dose of the active drug | Drug: low-dose<br>* Dosage 1<br>|
| Experimental: Group B (dosage 2)<br>The middle dose of the active drug | Drug: Middle-dose<br>* Dosage 2<br>|
| Experimental: Group C (dosage 3)<br>The higher dose of the active drug | Drug: Higher-dose<br>* Dosage 3<br>|
| Placebo Comparator: Group D (placebo)<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose-ranging, Kacip Fatimah, Labisia pumila, obesity