Obesity
Conditions
Keywords
dose-ranging, Kacip Fatimah, Labisia pumila, obesity
Brief summary
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
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.
Interventions
Sponsors
Medika Natura Sdn Bhd
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Active drug and placebo are made in similar
Intervention model description
4 parallel groups, 3 doses of study drug versus placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity 2. Willing to participate in the study by signing the informed consent 3. Healthy by anamnesis 4. Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.
Exclusion criteria
1. Positive result for Rapid test for COVID-19 at screening period. 2. Known hypersensitivity to any herbal product. 3. Pregnant or lactating women. 4. Taking any other weight loss therapy and/or lipid lowering products. 5. Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | 12 weeks | Change in BMI in kg/m\^2 |
| Change in body weight | 12 weeks | Percentage of subjects whose Body Weight is lowered |
| Change in waist and hip circumferences | 12 weeks | Change in waist and hip circumference |
| Change in the waist-hip and waist-height ratios | 12 weeks | Change in waist-hip ratio and waist-height ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat percentage | 12 weeks | The change of body fat percentage |
| Lean Body Mass | 12 weeks | The amount of lean body mass will be calculated from body fat percentage |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal vital signs and of abnormal laboratory test results | 12 weeks | Abnormality of vital signs and laboratory test results |
| Incidence of Adverse Events | 12 weeks | The incidence and percentage of Adverse events and serious adverse events |
Countries
Indonesia
Outcome results
None listed