NCT03899454

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

March 28, 2019

Last Update Submit

July 26, 2019

Conditions

Exertion; ExcessOxidative Stress

Keywords

exercise-induced oxidative-stressGarcinia mangostana L rind

Outcome Measures

Primary Outcomes (2)

  • Change ergo-cycle exercise test response to MDA level after 4 weeks treatment

    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

    measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels

    4 weeks

Secondary Outcomes (1)

  • Change from baseline MDA levels after 4 weeks treatment

    4 weeks

Study Arms (2)

Extract administration

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo Control

Interventions

Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extractDRUG

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

Also known as: Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)
Extract administration
Placebo ControlDRUG

Placebo Control

Also known as: placebo
Control

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary lifestyle
  • apparently healthy person
  • willing to use the smart-phone application for diet and physical activity monitoring

You may not qualify if:

  • pathological appearance in ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Negeri Semarang

Semarang, Central Java, 50229, Indonesia

Location

Related Publications (8)

  • Knez WL, Jenkins DG, Coombes JS. Oxidative stress in half and full Ironman triathletes. Med Sci Sports Exerc. 2007 Feb;39(2):283-8. doi: 10.1249/01.mss.0000246999.09718.0c.

    PMID: 17277592BACKGROUND

  • Thompson PD, Stern MP, Williams P, Duncan K, Haskell WL, Wood PD. Death during jogging or running. A study of 18 cases. JAMA. 1979 Sep 21;242(12):1265-7.

    PMID: 480538BACKGROUND

  • Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679.

    PMID: 20102930BACKGROUND

  • Tong TK, Kong Z, Lin H, He Y, Lippi G, Shi Q, Zhang H, Nie J. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial. Oxid Med Cell Longev. 2016;2016:4848015. doi: 10.1155/2016/4848015. Epub 2015 Dec 10.

    PMID: 26783415BACKGROUND

  • Tjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014

    BACKGROUND

  • Sutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013

    BACKGROUND

  • Meechai I, Phupong W, Chunglok W, Meepowpan P. Dihydroosajaxanthone: A New Natural Xanthone from the Branches of Garcinia Schomburgkiana Pierre. Iran J Pharm Res. 2018 Fall;17(4):1347-1352.

    PMID: 30568693BACKGROUND

  • Ali Hassan SH, Fry JR, Abu Bakar MF. Phytochemicals content, antioxidant activity and acetylcholinesterase inhibition properties of indigenous Garcinia parvifolia fruit. Biomed Res Int. 2013;2013:138950. doi: 10.1155/2013/138950. Epub 2013 Oct 31.

    PMID: 24288662BACKGROUND

Study Officials

  • Mahalul Azam

    Universitas Negeri Semarang

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahalul Azam, MD, PhD

CONTACT

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

Arulita Ika Fibriana, MD

CONTACT

08122921558arulita.ika.f@mail.unnes.ac.id

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two arm treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 2, 2019

Study Start

July 15, 2020

Primary Completion

September 15, 2020

Study Completion

September 15, 2022

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

ID(1)