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Dose-ranging Study of SKF7™ for Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557267
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
Medika Natura Sdn Bhd
Information provided by (Responsible Party):
Nafrialdi, Indonesia University

Study Description
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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™).

Condition or disease Intervention/treatment Phase
Obesity Drug: low-dose Drug: Middle-dose Drug: Higher-dose Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 parallel groups, 3 doses of study drug versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active drug and placebo are made in similar
Primary Purpose: Supportive Care
Official Title: Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study
Actual Study Start Date : September 30, 2020
Actual Primary Completion Date : May 20, 2021
Actual Study Completion Date : May 22, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557267


Locations
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Indonesia
Indonesia Medical Education and Research Institute
Jakarta, DKI Jakarta, Indonesia, 10430
Faculty of Medicine, Krida Wacana Christian University
Jakarta, DKI Jakarta, Indonesia, 11510
Makara Satellite Clinic
Depok, West Java, Indonesia, 16424
Sponsors and Collaborators
Indonesia University
Medika Natura Sdn Bhd
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Nafrialdi, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04557267    
Other Study ID Numbers: CRSU.P.SKF7F2/1019/04.08
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nafrialdi, Indonesia University:
dose-ranging
Kacip Fatimah
Labisia pumila
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight