Clinical trial NCT04557267: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: dose-ranging
Kacip Fatimah
Labisia pumila
obesity
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Medika Natura Sdn Bhd
First posted: 2020-09-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 parallel groups, 3 doses of study drug versus placebo
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
measure: Change in waist and hip circumferences
timeFrame: 12 weeks
measure: Change in the waist-hip and waist-height ratios
timeFrame: 12 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 12 weeks
measure: Lean Body Mass
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of abnormal vital signs and of abnormal laboratory test results
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 12 weeks
Locations:
city: Jakarta
country: Indonesia
facility: Indonesia Medical Education and Research Institute
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Faculty of Medicine, Krida Wacana Christian University
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Makara Satellite Clinic
state: West Java
Study officials:
affiliation: Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
name: Arini Setiawati, PhD
role: STUDY_CHAIR
affiliation: Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia
name: Nafrialdi Agus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.