Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change ergo-cycle exercise test response to MDA level after 4 weeks treatment
研究概览
简要总结
Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
详细描述
Double-blinded Randomized Clinical Trial
The population of study will involve sedentary men, the student in Universitas Negeri Semarang aged 18-25 years old, targetted populations are 30 subjects consist of 15 treatment group and the rest 15 placebo-control group. Voluntary sampling will be conducted. Information to the candidates delivered directly, leaflets, and social media broadcasting.
Two arm treatment to be given is an administration of a mixture extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
The administration of extract treatment and placebo will be given for four weeks.
The primary effect that will be observed is the changes in malondialdehyde (MDA) and high-sensitivity Cardiac-Troponin I (hs-cTnI) level after an ergo-cycle exercise test.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •sedentary lifestyle
- •apparently healthy person
- •willing to use the smart-phone application for diet and physical activity monitoring
排除标准
- •pathological appearance in ECG
研究组 & 干预措施
Extract administration
administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
干预措施: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract (Drug)
Control
Placebo
干预措施: Placebo Control (Drug)
结局指标
主要结局
Change ergo-cycle exercise test response to MDA level after 4 weeks treatment
时间窗: 4 weeks
measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels
Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment
时间窗: 4 weeks
measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels
次要结局
- Change from baseline MDA levels after 4 weeks treatment(4 weeks)
研究者
Mahalul Azam
Principle Investigator
Universitas Negeri Semarang