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| Name | Class |
|---|---|
| Ministry of Research, Technology and Higher Education, Republic of Indonesia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract administration | Experimental | administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) |
|
| Control | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract | Drug | Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline MDA levels after 4 weeks treatment | measuring MDA levels baseline and post-treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahalul Azam, MD, PhD | Contact | +628122853982 | mahalul.azam@mail.unnes.ac.id | |
| Arulita Ika Fibriana, MD | Contact | 08122921558 | arulita.ika.f@mail.unnes.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Mahalul Azam | Universitas Negeri Semarang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Negeri Semarang | Semarang | Central Java | 50229 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17277592 | Background | Knez WL, Jenkins DG, Coombes JS. Oxidative stress in half and full Ironman triathletes. Med Sci Sports Exerc. 2007 Feb;39(2):283-8. doi: 10.1249/01.mss.0000246999.09718.0c. | |
| 480538 | Background | Thompson PD, Stern MP, Williams P, Duncan K, Haskell WL, Wood PD. Death during jogging or running. A study of 18 cases. JAMA. 1979 Sep 21;242(12):1265-7. |
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two arm treatment
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| Placebo Control | Drug | Placebo Control |
|
|
| 20102930 | Background | Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679. |
| 26783415 | Background | Tong TK, Kong Z, Lin H, He Y, Lippi G, Shi Q, Zhang H, Nie J. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial. Oxid Med Cell Longev. 2016;2016:4848015. doi: 10.1155/2016/4848015. Epub 2015 Dec 10. |
| Background | Tjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014 |
| Background | Sutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013 |
| 30568693 | Background | Meechai I, Phupong W, Chunglok W, Meepowpan P. Dihydroosajaxanthone: A New Natural Xanthone from the Branches of Garcinia Schomburgkiana Pierre. Iran J Pharm Res. 2018 Fall;17(4):1347-1352. |
| 24288662 | Background | Ali Hassan SH, Fry JR, Abu Bakar MF. Phytochemicals content, antioxidant activity and acetylcholinesterase inhibition properties of indigenous Garcinia parvifolia fruit. Biomed Res Int. 2013;2013:138950. doi: 10.1155/2013/138950. Epub 2013 Oct 31. |