search
Back to results

Dose-ranging Study of SKF7™ for Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
low-dose
Middle-dose
Higher-dose
Placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring dose-ranging, Kacip Fatimah, Labisia pumila, obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Indonesia Medical Education and Research Institute
  • Faculty of Medicine, Krida Wacana Christian University
  • Makara Satellite Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A (dosage A)

Group B (dosage 2)

Group C (dosage 3)

Group D (placebo)

Arm Description

The lower dose of the active drug

The middle dose of the active drug

The higher dose of the active drug

Placebo

Outcomes

Primary Outcome Measures

Change in body weight
Percentage of subjects whose Body Weight is lowered
Change in waist and hip circumferences
Change in waist and hip circumference
Change in the waist-hip and waist-height ratios
Change in waist-hip ratio and waist-height ratio
Change in Body Mass Index (BMI)
Change in BMI in kg/m^2

Secondary Outcome Measures

Body fat percentage
The change of body fat percentage
Lean Body Mass
The amount of lean body mass will be calculated from body fat percentage

Full Information

First Posted
September 7, 2020
Last Updated
June 2, 2021
Sponsor
Indonesia University
Collaborators
Medika Natura Sdn Bhd
search

1. Study Identification

Unique Protocol Identification Number
NCT04557267
Brief Title
Dose-ranging Study of SKF7™ for Obesity
Official Title
Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Medika Natura Sdn Bhd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
dose-ranging, Kacip Fatimah, Labisia pumila, obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
4 parallel groups, 3 doses of study drug versus placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Active drug and placebo are made in similar
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (dosage A)
Arm Type
Experimental
Arm Description
The lower dose of the active drug
Arm Title
Group B (dosage 2)
Arm Type
Experimental
Arm Description
The middle dose of the active drug
Arm Title
Group C (dosage 3)
Arm Type
Experimental
Arm Description
The higher dose of the active drug
Arm Title
Group D (placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
low-dose
Intervention Description
Dosage 1
Intervention Type
Drug
Intervention Name(s)
Middle-dose
Intervention Description
Dosage 2
Intervention Type
Drug
Intervention Name(s)
Higher-dose
Intervention Description
Dosage 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in body weight
Description
Percentage of subjects whose Body Weight is lowered
Time Frame
12 weeks
Title
Change in waist and hip circumferences
Description
Change in waist and hip circumference
Time Frame
12 weeks
Title
Change in the waist-hip and waist-height ratios
Description
Change in waist-hip ratio and waist-height ratio
Time Frame
12 weeks
Title
Change in Body Mass Index (BMI)
Description
Change in BMI in kg/m^2
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
The change of body fat percentage
Time Frame
12 weeks
Title
Lean Body Mass
Description
The amount of lean body mass will be calculated from body fat percentage
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of abnormal vital signs and of abnormal laboratory test results
Description
Abnormality of vital signs and laboratory test results
Time Frame
12 weeks
Title
Incidence of Adverse Events
Description
The incidence and percentage of Adverse events and serious adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arini Setiawati, PhD
Organizational Affiliation
Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nafrialdi Agus, MD, PhD
Organizational Affiliation
Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indonesia Medical Education and Research Institute
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Faculty of Medicine, Krida Wacana Christian University
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
11510
Country
Indonesia
Facility Name
Makara Satellite Clinic
City
Depok
State/Province
West Java
ZIP/Postal Code
16424
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30235727
Citation
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.
Results Reference
result
Links:
URL
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-medicinal-products-used-weight-management-revision-1_en.pdf
Description
EMA Guideline on clinical evaluation of medicinal products used in weight control
URL
https://apps.who.int/iris/handle/10665/206936
Description
The Asia-Pacific Perspective: Redefining Obesity and its Treatment

Learn more about this trial

Dose-ranging Study of SKF7™ for Obesity

We'll reach out to this number within 24 hrs