Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The secondary effect of the treatment that will be observed is the baseline and post-treatment parameters of MDA levels.

Official Title
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Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress

Conditions
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Exertion; Excess, Oxidative Stress

Intervention / Treatment
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* Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract
* Drug: Placebo Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sedentary lifestyle apparently healthy person willing to use the smart-phone application for diet and physical activity monitoring Exclusion Criteria: pathological appearance in ECG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arm treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extract administration<br>administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) | Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract<br>* Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)<br>* Other names: Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351);|
| Placebo Comparator: Control<br>Placebo | Drug: Placebo Control<br>* Placebo Control<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change ergo-cycle exercise test response to MDA level after 4 weeks treatment | measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels | 4 weeks | 
| Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment | measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline MDA levels after 4 weeks treatment | measuring MDA levels baseline and post-treatment | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise-induced oxidative-stress, Garcinia mangostana L rind