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

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™).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: low-dose; Drug: Middle-dose; Drug: Higher-dose

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Indonesia Medical Education and Research Institute
    • Jakarta, DKI Jakarta, Indonesia, 11510
      • Faculty of Medicine, Krida Wacana Christian University
  • West Java
    • Depok, West Java, Indonesia, 16424
      • Makara Satellite Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of abnormal vital signs and of abnormal laboratory test results	Abnormality of vital signs and laboratory test results	12 weeks
Incidence of Adverse Events	The incidence and percentage of Adverse events and serious adverse events	12 weeks

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Medika Natura Sdn Bhd
• Investigators: Study Chair: Arini Setiawati, PhD, Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia; Principal Investigator: Nafrialdi Agus, MD, PhD, Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia

Publications and helpful links

General Publications

• Lee S, Lee H, Cho Y, Kim J, Kang JW, Seo BK, Baek YH, Lee JD. The efficacy and safety of Hanslim for obese patients: Study protocol for a multicenter, randomized, double-blind, multi-dose, placebo-controlled, phase IIb clinical trial. Medicine (Baltimore). 2018 Sep;97(38):e12440. doi: 10.1097/MD.0000000000012440.

Helpful Links

• EMA Guideline on clinical evaluation of medicinal products used in weight control
• The Asia-Pacific Perspective: Redefining Obesity and its Treatment

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 22, 2021

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: obesity; Labisia pumila; dose-ranging; Kacip Fatimah
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CRSU.P.SKF7F2/1019/04.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No