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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
Sponsor:
Collaborator:
Ministry of Research, Technology and Higher Education, Republic of Indonesia
Information provided by (Responsible Party):
Mahalul Azam, Universitas Negeri Semarang

Brief Summary:
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.

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two arm treatment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Placebo
Drug: Placebo Control
Placebo Control
Other Name: placebo




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change from baseline MDA levels after 4 weeks treatment [ Time Frame: 4 weeks ]
    measuring MDA levels baseline and post-treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mahalul Azam, MD, PhD +628122853982 mahalul.azam@mail.unnes.ac.id
Contact: Arulita Ika Fibriana, MD 08122921558 arulita.ika.f@mail.unnes.ac.id

Locations
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Indonesia
Universitas Negeri Semarang
Semarang, Jawa Tengah, Indonesia, 50229
Sponsors and Collaborators
Universitas Negeri Semarang
Ministry of Research, Technology and Higher Education, Republic of Indonesia
Investigators
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Principal Investigator: Mahalul Azam Universitas Negeri Semarang

Publications:
Tjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014
Sutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013

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Responsible Party: Mahalul Azam, Principle Investigator, Universitas Negeri Semarang
ClinicalTrials.gov Identifier: NCT03899454     History of Changes
Other Study ID Numbers: RCT 201901
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahalul Azam, Universitas Negeri Semarang:
exercise-induced oxidative-stress
Garcinia mangostana L rind