Dose-ranging Study of SKF7™ for Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-05-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 parallel groups, 3 doses of study drug versus placebo

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Active drug and placebo are made in similar

Study Groups

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Group A (dosage A)

The lower dose of the active drug

Group Type EXPERIMENTAL

low-dose

Intervention Type DRUG

Dosage 1

Group B (dosage 2)

The middle dose of the active drug

Group Type EXPERIMENTAL

Middle-dose

Intervention Type DRUG

Dosage 2

Group C (dosage 3)

The higher dose of the active drug

Group Type EXPERIMENTAL

Higher-dose

Intervention Type DRUG

Dosage 3

Group D (placebo)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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low-dose

Dosage 1

Intervention Type DRUG

Middle-dose

Dosage 2

Intervention Type DRUG

Higher-dose

Dosage 3

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes