Dose-ranging Study of SKF7™ for Obesity

University of Indonesia (UI)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Higher-dose; Drug: low-dose; Drug: Middle-dose; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04557267

CRSU.P.SKF7F2/1019/04.08

Details and patient eligibility

About

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™).

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Group A (dosage A)

Experimental group

Description:

The lower dose of the active drug

Treatment:

Drug: low-dose

Group B (dosage 2)

Experimental group

Description:

The middle dose of the active drug

Treatment:

Drug: Middle-dose

Group C (dosage 3)

Experimental group

Description:

The higher dose of the active drug

Treatment:

Drug: Higher-dose

Group D (placebo)

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo