Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress (GMR-RCT-EOS)
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|ClinicalTrials.gov Identifier: NCT03899454|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Exertion; Excess Oxidative Stress||Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract Drug: Placebo Control||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||two arm treatment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress|
|Estimated Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||September 15, 2022|
Experimental: Extract administration
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
Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
Other Name: Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)
Placebo Comparator: Control
Drug: Placebo Control
Other Name: placebo
- Change ergo-cycle exercise test response to MDA level after 4 weeks treatment [ Time Frame: 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 [ Time Frame: 4 weeks ]measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels
- Change from baseline MDA levels after 4 weeks treatment [ Time Frame: 4 weeks ]measuring MDA levels baseline and post-treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899454
|Contact: Mahalul Azam, MD, PhDfirstname.lastname@example.org|
|Contact: Arulita Ika Fibriana, MDemail@example.com|
|Universitas Negeri Semarang|
|Semarang, Jawa Tengah, Indonesia, 50229|
|Principal Investigator:||Mahalul Azam||Universitas Negeri Semarang|