Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Change in body weight
研究概览
简要总结
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™).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active drug and placebo are made in similar
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity
- •Willing to participate in the study by signing the informed consent
- •Healthy by anamnesis
- •Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.
排除标准
- •Positive result for Rapid test for COVID-19 at screening period.
- •Known hypersensitivity to any herbal product.
- •Pregnant or lactating women.
- •Taking any other weight loss therapy and/or lipid lowering products.
- •Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
研究组 & 干预措施
Group A (dosage A)
The lower dose of the active drug
干预措施: low-dose (Drug)
Group B (dosage 2)
The middle dose of the active drug
干预措施: Middle-dose (Drug)
Group C (dosage 3)
The higher dose of the active drug
干预措施: Higher-dose (Drug)
Group D (placebo)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in body weight
时间窗: 12 weeks
Percentage of subjects whose Body Weight is lowered
Change in waist and hip circumferences
时间窗: 12 weeks
Change in waist and hip circumference
Change in the waist-hip and waist-height ratios
时间窗: 12 weeks
Change in waist-hip ratio and waist-height ratio
Change in Body Mass Index (BMI)
时间窗: 12 weeks
Change in BMI in kg/m\^2
次要结局
- Body fat percentage(12 weeks)
- Lean Body Mass(12 weeks)
研究者
Nafrialdi
Principal Investigator
Indonesia University