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OpenTrials
Completed

NCT Number: NCT04557267

Dose-ranging Study of SKF7™ for Obesity

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Krida Wacana Christian University, Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity
  • Willing to participate in the study by signing the informed consent
  • Healthy by anamnesis
  • Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.

Exclusion criteria

  • Positive result for Rapid test for COVID-19 at screening period.
  • Known hypersensitivity to any herbal product.
  • Pregnant or lactating women.
  • Taking any other weight loss therapy and/or lipid lowering products.
  • Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.

Treatment and study plan

low-dose

Drug

Dosage 1

Middle-dose

Drug

Dosage 2

Higher-dose

Drug

Dosage 3

Placebo

Drug

Placebo

Primary outcomes

  1. Change in body weight

    Time frame: 12 weeks

    Percentage of subjects whose Body Weight is lowered

  2. Change in waist and hip circumferences

    Time frame: 12 weeks

    Change in waist and hip circumference

  3. Change in the waist-hip and waist-height ratios

    Time frame: 12 weeks

    Change in waist-hip ratio and waist-height ratio

  4. Change in Body Mass Index (BMI)

    Time frame: 12 weeks

    Change in BMI in kg/m^2

Secondary outcomes

  1. Body fat percentage

    Time frame: 12 weeks

    The change of body fat percentage

  2. Lean Body Mass

    Time frame: 12 weeks

    The amount of lean body mass will be calculated from body fat percentage

Other outcomes

  1. Incidence of abnormal vital signs and of abnormal laboratory test results

    Time frame: 12 weeks

    Abnormality of vital signs and laboratory test results

  2. Incidence of Adverse Events

    Time frame: 12 weeks

    The incidence and percentage of Adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Medika Natura Sdn Bhd

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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