A Randomized, Double-blind Placebo-controlled Phase 1 Trial of Lessertia Frutescens in Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Lessertia frutescens (L.) Goldblatt & J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to combat cancer, infections and symptoms associated with AIDS. The aim of this study was to evaluate the safety of this phytotherapy in healthy adults.
详细描述
Objectives: Lessertia frutescens (L.) Goldblatt & J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to combat cancer, infections and symptoms associated with AIDS. The aim of this study was to evaluate the safety of this phytotherapy in healthy adults.
Design: A randomised, double blind, placebo-controlled trial to evaluate the safety of Lessertia frutescens in healthy adults.
Setting: Karl Bremer Hospital, Bellville, South Africa.
Participants: 25 adults, aged 18 to 45 years, who provided informed consent. They had no significant diseases or clinically abnormal laboratory blood profiles during screening. They had no history of allergic conditions and were not on regular medical treatment.
Intervention: 12 healthy participants were randomized to a treatment arm where they received 400mg L. frutescens leaf powder capsules twice daily (800mg/day), available as a product called Sutherlandia. 13 healthy participants were randomized to the control arm, where they received an identical placebo capsule. The trial lasted 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between 18 and 45 years of age will:
- •be informed of the nature of the study and will give written informed consent;
- •have body weights within 25% of the appropriate range;
- •have no significant decreases or clinically abnormal laboratory values during screening;
- •have 12 lead ECG without significant abnormalities;
- •be on no regular medical treatment;
- •be able to communicate effectively with study personnel.
排除标准
- •Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous system, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •History of allergic conditions - asthma, urticaria and eczema.
- •History of autoimmune disorders - Lupus erythematosis.
- •History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
- •History of psychiatric disorders.
- •Intake of any medication within 14 days before the start of the study.
- •Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
- •Smokers who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period.
- •Presence of clinically significant abnormal laboratory results during screening.
- •Pregnancy or not using appropriate means of contraception.
- •Use of any recreational drugs or a history of drug addiction.
研究组 & 干预措施
Lessertia Fructescens
Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
干预措施: Lessertia Fructescens (Drug)
Placebo
Participants received an identical placebo capsule twice daily for 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Through end of study
次要结局
- Change in appetite(Through end of study)
- Change in study drug biomarker levels(Through end of study)
- Change in complete blood count(Through end of study)
- Change in serum albumin levels(Through end of study)
- Change in respiration rate(Through end of study)
- Change in serum protein levels(Through end of study)