Dose-ranging Study of SKF7™ for Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557267
• Other study ID #: CRSU.P.SKF7F2/1019/04.08
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2020
• Est. completion date: May 22, 2021

Study information

• Verified date: June 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 22, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• low-dose
Dosage 1
• Middle-dose
Dosage 2
• Higher-dose
Dosage 3
• Placebo
Placebo

Locations

Country	Name	City	State
Indonesia	Makara Satellite Clinic	Depok	West Java
Indonesia	Faculty of Medicine, Krida Wacana Christian University	Jakarta	DKI Jakarta
Indonesia	Indonesia Medical Education and Research Institute	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Medika Natura Sdn Bhd

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of abnormal vital signs and of abnormal laboratory test results	Abnormality of vital signs and laboratory test results	12 weeks
Other	Incidence of Adverse Events	The incidence and percentage of Adverse events and serious adverse events	12 weeks
Primary	Change in body weight	Percentage of subjects whose Body Weight is lowered	12 weeks
Primary	Change in waist and hip circumferences	Change in waist and hip circumference	12 weeks
Primary	Change in the waist-hip and waist-height ratios	Change in waist-hip ratio and waist-height ratio	12 weeks
Primary	Change in Body Mass Index (BMI)	Change in BMI in kg/m^2	12 weeks
Secondary	Body fat percentage	The change of body fat percentage	12 weeks
Secondary	Lean Body Mass	The amount of lean body mass will be calculated from body fat percentage	12 weeks

External Links

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