Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress (GMR-RCT-EOS)

Universitas Negeri Semarang

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Oxidative Stress; Exertion; Excess

Treatments: Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract; Drug: Placebo Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03899454

RCT 201901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Extract administration

Experimental group

Description:

administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)

Treatment:

Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract

Control

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Control