Clincosm LogoSign in Get a demo

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

Sponsor
Universitas Negeri Semarang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03899454
Collaborator
Ministry of Research, Technology and Higher Education, Republic of Indonesia (Other)
30
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two arm treatmenttwo 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
Anticipated Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Sep 15, 2020
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

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 Names:
  • Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)

    		•
    Placebo Comparator: Control

    Placebo

    Drug: Placebo Control
    Placebo Control
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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 Outcome Measures

    1. Change from baseline MDA levels after 4 weeks treatment [4 weeks]

      measuring MDA levels baseline and post-treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Mahalul Azam, Universitas Negeri Semarang

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahalul Azam, Principle Investigator, Universitas Negeri Semarang
    ClinicalTrials.gov Identifier:
    NCT03899454
    Other Study ID Numbers:
    • RCT 201901
    First Posted:
    Apr 2, 2019
    Last Update Posted:
    Jul 30, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahalul Azam, Principle Investigator, Universitas Negeri Semarang
    exercise-induced oxidative-stress
    Garcinia mangostana L rind

    Study Results

    No Results Posted as of Jul 30, 2019