NCT03899454

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universitas Negeri Semarang · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Exertion; Excess
• Oxidative Stress

Interventions

Type	Name	Description
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)
DRUG	Placebo Control	Placebo Control

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-09-15
• Completion: 2022-09-15
• First posted: 2019-04-02
• Last updated: 2019-07-30

Locations

1 site across 1 country: Indonesia