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

July 26, 2019 updated by: Mahalul Azam, Universitas Negeri Semarang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Jawa Tengah
      • Semarang, Jawa Tengah, Indonesia, 50229
        • Universitas Negeri Semarang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo
Drug: Placebo Control
Placebo Control
Other Names:
  • placebo
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 Names:
  • Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
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
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Negeri Semarang

Collaborators

Ministry of Research, Technology and Higher Education, Republic of Indonesia

Investigators

  • Principal Investigator: Mahalul Azam, Universitas Negeri Semarang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2020

Primary Completion (Anticipated)

September 15, 2020

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT 201901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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