low-dose
DrugDosage 1
NCT Number: NCT04557267
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™).
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Notify Me18 year–50 year
All sexes
Interventional
Phase 2
Faculty of Medicine, Krida Wacana Christian University, Jakarta, DKI Jakarta, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dosage 1
Dosage 2
Dosage 3
Placebo
Time frame: 12 weeks
Percentage of subjects whose Body Weight is lowered
Time frame: 12 weeks
Change in waist and hip circumference
Time frame: 12 weeks
Change in waist-hip ratio and waist-height ratio
Time frame: 12 weeks
Change in BMI in kg/m^2
Time frame: 12 weeks
The change of body fat percentage
Time frame: 12 weeks
The amount of lean body mass will be calculated from body fat percentage
Time frame: 12 weeks
Abnormality of vital signs and laboratory test results
Time frame: 12 weeks
The incidence and percentage of Adverse events and serious adverse events
Indonesia University
Other
Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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