A Phase 2 interventional study of low-dose and Middle-dose in Obesity, sponsored by Indonesia University. Completed at 3 sites in Indonesia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by Indonesia University · Phase 2, Interventional, and Supportive care
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™).
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 160 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The lower dose of the active drug
Drug: low-dose
The middle dose of the active drug
Drug: Middle-dose
The higher dose of the active drug
Drug: Higher-dose
Placebo
Drug: Placebo
Dosage 1
Dosage 2
Dosage 3
Placebo
Change in body weight
Percentage of subjects whose Body Weight is lowered
Time frame: 12 weeks
Change in waist and hip circumferences
Change in waist and hip circumference
Time frame: 12 weeks
Change in the waist-hip and waist-height ratios
Change in waist-hip ratio and waist-height ratio
Time frame: 12 weeks
Change in Body Mass Index (BMI)
Change in BMI in kg/m\^2
Time frame: 12 weeks
Body fat percentage
The change of body fat percentage
Time frame: 12 weeks
Lean Body Mass
The amount of lean body mass will be calculated from body fat percentage
Time frame: 12 weeks
Incidence of abnormal vital signs and of abnormal laboratory test results
Abnormality of vital signs and laboratory test results
Time frame: 12 weeks
Incidence of Adverse Events
The incidence and percentage of Adverse events and serious adverse events
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indonesia University