NCT04557267

Dose-ranging Study of SKF7™ for Obesity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	low-dose	Dosage 1
DRUG	Middle-dose	Dosage 2
DRUG	Higher-dose	Dosage 3
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-05-20
• Completion: 2021-05-22
• First posted: 2020-09-21
• Last updated: 2021-06-03

Locations

3 sites across 1 country: Indonesia