Dose-ranging Study of SKF7™ for Obesity

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: low-dose; Drug: Middle-dose; Drug: Higher-dose; Drug: Placebo

• Registration Number: NCT04557267
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2020-09-30
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-22
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (dosage A)	low-dose	The lower dose of the active drug
Group B (dosage 2)	Middle-dose	The middle dose of the active drug
Group C (dosage 3)	Higher-dose	The higher dose of the active drug
Group D (placebo)	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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
Change in Body Mass Index (BMI)	12 weeks	Change in BMI in kg/m\^2

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Indonesia Medical Education and Research Institute; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Faculty of Medicine, Krida Wacana Christian University; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Makara Satellite Clinic; 🇮🇩 Depok, West Java, Indonesia