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

NCT ID: NCT03899454

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-09-15

Brief Summary

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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

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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

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Exertion; Excess Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two arm treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Extract administration

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Control

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DRUG

Placebo Control

Interventions

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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)

Intervention Type DRUG

Placebo Control

Placebo Control

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Universitas Negeri Semarang

OTHER

Sponsor Role lead

Responsible Party

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Mahalul Azam

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahalul Azam

Role: PRINCIPAL_INVESTIGATOR

Universitas Negeri Semarang

Locations

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Universitas Negeri Semarang

Semarang, Central Java, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Mahalul Azam, MD, PhD

Role: CONTACT

+628122853982

Arulita Ika Fibriana, MD

Role: CONTACT

08122921558

References

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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.

Reference Type BACKGROUND
PMID: 17277592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 480538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20102930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26783415 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30568693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24288662 (View on PubMed)

Other Identifiers

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RCT 201901

Identifier Type: -

Identifier Source: org_study_id

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