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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03899454

Acronym

GMR-RCT-EOS

Enrollment

Registered

2019-04-02

Start date

2020-07-15

Completion date

2022-09-15

Last updated

2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exertion; Excess, Oxidative Stress

Keywords

exercise-induced oxidative-stress, Garcinia mangostana L rind

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.

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.

Interventions

DRUGGarcinia-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)

DRUGPlacebo Control

Placebo Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

two arm treatment

Eligibility

Sex/Gender

MALE

Age

18 Years to 25 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Indonesia

Contacts

Primary ContactMahalul Azam, MD, PhD

mahalul.azam@mail.unnes.ac.id+628122853982

Backup ContactArulita Ika Fibriana, MD

arulita.ika.f@mail.unnes.ac.id08122921558

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026