Dose-ranging Study of Labisia Pumila 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
- 发起方
- 入组人数
- 142
- 试验地点
- 6
- 主要终点
- Percentage of patients achieving more than or equal to 5% weight loss OR
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. One group will receive placebo alone and the other three groups will receive IP twice daily (different dosages) for four months.
详细描述
Labisia pumila or Kacip Fatimah, a native Malaysian plant, has been used as traditional medicine for over 400 years by both men and women for multiple treatments. Studies in animal models showed that Labisia pumila extract could regulate body weight gain and visceral fat reduction. SKF7® is a standardized extract of Labisia pumila (Kacip Fatimah) from the Myrsinaceae family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men aged 18 - 60 years.
- •Women aged 18 until before menopause.
- •BMI 30 - 37 kg/m
- •Waist circumference ≥ 60% of height.
- •Generally healthy or in the presence of co-morbidities of treated or untreated hypertension, diabetes or hyperlipidaemia.
- •Normotension or well-controlled mild hypertension (< 140/90 mmHg) with stable dosage of not more than 2 class drug combination (except beta blocker and diuretic) for at least 1 month.
- •Normoglycemic or non-insulin dependent diabetes mellitus (HbA1c ≤ 8.5%) with stable dosage of not more than 2 class drug combination (except sulphonylureas, TZDs and SGLT2 inhibitors) for at least 1 month.
- •Normolipidaemia or hyperlipidaemia (LDL ≤ 4.1 mmol/L and TG ≤ 5.6 mmol/L) with stable dosage of not more than 2 class drug combination for at least 1 month.
- •Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.
- •Willing to participate in the study by signing the informed consent.
- •Ability to provide written informed consent.
排除标准
- •Known hypersensitivity to any herbal product.
- •Known history of allergic reaction to microcrystalline cellulose, maltodextrin, tricalcium phosphate, silicon dioxide and glyceryl monostearate.
- •Pregnant or lactating women.
- •Taking any other weight loss therapy or who have lost more than 10% of their body weight within the last 6 months.
- •Taking regular herbal drugs or any supplements unless subjects willing to stop during the study.
- •Known HIV subjects.
- •Severe liver function impairment (ALT & AST > 3x ULN (upper limit of normal)
- •Renal function impairment (serum creatinine > 132.6 µmol/L)
- •Participating in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
- •Having endocrine disease that may affect weight such as hypothyroidism or Cushing's syndrome (by anamnesis).
- •Taking hormonal contraceptive within the last 3 months or planning to use it during the study.
- •Female patient of childbearing potential who is planning to get pregnant/male patient who is planning to have a child or do not agree to use non-hormonal contraception for the entire duration of the study.
- •Having heart diseases (e.g. heart failure, angina pectoris, or myocardial infarction), respiratory diseases (e.g. asthma or obstructive pulmonary disease), stroke, or ischemic heart failure.
- •Having malignant tumors within the last 5 years.
- •Participants who have narrow-angle glaucoma.
- •Participants who have cholelithiasis.
- •Participants with a neurologically or psychologically significant history of disease or who are currently suffering from the disease (e.g. schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, hyperphagia, etc.).
- •Participants who have taken oral steroids (e.g. prednisone or its equivalent) within the last 3 months that may affect weight.
- •Participants who have taken b-blocker or diuretic drugs for hypertension, anorexiants, laxatives, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, contraceptive or female hormones within the last 3 months that may affect weight.
- •Participants who have taken other treatments (e.g. insulin, blood thinning, antidepressants, selective serotonin reuptake inhibitors (SSRIs), barbiturate, antipsychotics, antiepileptic, or drugs concerned with abuse) within the last 5 years.
- •Participants who have anatomical condition or underwent anatomical changes which make it difficult/unable to conduct physical measurements.
- •Participants who underwent surgeries for weight reduction (e.g., gastroplasty or gastrectomy).
- •Participants who are judged as unable to comply with the study according to the findings of the clinical investigator.
研究组 & 干预措施
Placebo
Placebo
干预措施: SKF7® Labisia pumila standardized extract (Other)
SKF7® - 375 mg
Patients who meet the entry criteria for the study will be randomized to receive 375 mg SKF7® for 16 weeks
干预措施: SKF7® Labisia pumila standardized extract (Other)
SKF7® - 562.5 mg
Patients who meet the entry criteria for the study will be randomized to receive 562.5 mg SKF7® for 16 weeks
干预措施: SKF7® Labisia pumila standardized extract (Other)
SKF7® - 750 mg
Patients who meet the entry criteria for the study will be randomised to receive 750 mg SKF7® for 16 weeks
干预措施: SKF7® Labisia pumila standardized extract (Other)
结局指标
主要结局
Percentage of patients achieving more than or equal to 5% weight loss OR
时间窗: Baseline Day 1 to Week 16
Percentage of patients achieving more than or equal to 5% weight loss for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Percentage of patients achieving more than or equal to 5 cm waist circumference reduction
时间窗: Baseline Day 1 to Week 16
Percentage of patients achieving more than or equal to 5 cm waist circumference reduction for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
次要结局
- Percentage change from baseline in body weight (kg) at week 16(Baseline Day 1 to Week 16)
- Percentage change from baseline in BMI at week 16(Baseline Day 1 to Week 16)
- Percentage change from baseline in waist circumference (cm) at week 16(Baseline Day 1 to Week 16)
- Percentage change from baseline in waist to height ratio at week 16(Baseline Day 1 to Week 16)
- Change in blood lipid concentrations.(Baseline Day 1 to Week 16)
- Incidence of AEs, SAEs and AEs leading to early discontinuation(Up to Follow up visit Up to Week 17)