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Development The Potentiality of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) From Mycelia Extract of Indonesia's Ganoderma Lucidum as Adjuvant Therapy in Patients With Cardiometabolic Syndrome

NCT ID: NCT05079529

Last Updated: 2021-10-15

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

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-01-06

Brief Summary

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The aim of this study is to determine the role and efficacy of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum as an antioxidant and anti-inflammatory agent on cardiometabolic syndrome

Detailed Description

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This study is held at Saiful Anwar General Hospital and General Hospital of Brawijaya University by enrolled 70 participants and using a double-blinded true experimental using a randomized control perspective method with pre-test and post-test design, to determine the effect of giving β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum on cardiometabolic syndrome population.

The intended target or experimental variables that will be studied in this study are blood pressure, body mass index, blood glucose profile (fasting glucose, HbA1C), lipid profile (total cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, and triglyceride), renal function profile (urea and creatinine), heart function from echocardiography examination, inflammation parameter (Interleukin 6, Tumor Necrosis Factor-Alpha, and high sensitivity C-Reactive Protein), stress oxidative parameter (superoxide dismutase and malondialdehyde), endothelial function parameter (nitric oxide), and quality of life that conducted by completion of the SF-36 questionnaire.

Hypothesis of this study is β-1,3/1,6-D-Glucan (Polysaccharide Peptide) from mycelia extract of Indonesia's Ganoderma lucidum can acts as a chronic anti-inflammatory and antioxidant agent in cardiometabolic syndrome patients by contributing in blood pressure control, body mass index control, blood glucose improvement, lipid profile improvement, renal function profile improvement, heart function improvement, and better quality of life. Beside that, the investigators hope that there will be a change of inflammation, stress oxidative, and endothelial function parameter in which shift to the good level.

Conditions

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Cardiometabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study conducted cardiometabolic syndrome patients based on NCEP-ATPIII criteria with modification of obesity classification to Asian population criteria. All of the participant would be divided into 2 groups/arms in which one group will be given Polysaccharide Peptide capsule 3 times daily for 90 days and the other one will be given Placebo in the same duration of time.

Before Polysaccharide Peptide is given, there will be a sequence of pre-test examination, include: blood pressure measurement, body weight and body height measurement to determine Body Mass Index status, waist circumference measurement, blood glucose profile, lipid profile, renal function profile, parameter of inflammation status, parameter of oxidative stress, parameter of endothelial function, and completion of SF 36 questionnaire in which all of them will be done as post-test after intervention completed.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This study is randomized control double-blinded true experimental study. So the only party that acknowledge whom is given Polysaccharide Peptide capsule or Placebo is the collaborator who provides the adjuvant therapy agent. There is an exception for Outcomes Assessor. They might ask for detail description of the intervention that have been given to the participant if there is any serious adverse event going on.

Study Groups

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β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group

This group will receive capsule contains 180 mg of β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma lucidum which will be taken 3 times daily for 90 days

Group Type EXPERIMENTAL

β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group

Intervention Type DRUG

Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days

Placebo Group

This group will receive empty capsule which will be taken 3 times daily for 90 days

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DRUG

Takes placebo capsule 3 times daily for 90 days

Interventions

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β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group

Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days

Intervention Type DRUG

Placebo Group

Takes placebo capsule 3 times daily for 90 days

Intervention Type DRUG

Other Intervention Names

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β-1,3/1,6-D-Glucan

Eligibility Criteria

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Inclusion Criteria

* Age more or same than 18 years old
* Defined as metabolic syndrome patients based on NCEP-ATP III Criteria with modified of obesity classification (waist measurement) for Asian population
* Agreed to participate in this study

Exclusion Criteria

* Allergic to Ganoderma lucidum
* Pregnant woman
* Participate in another drug or medical device study
* Waiting for an organ transplantation or have undergone a transplant
* Cancer patients who undergoing a chemotherapy or radiotherapy
* People with organ failure
* Could not be randomized and participate in this study by clinical judgement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PT. Sahabat Lingkungan Hidup

UNKNOWN

Sponsor Role collaborator

University of Brawijaya

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. dr. Djanggan Sargowo, Sp.PD, Sp.JP(K)

Prof, Ph.d, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)

Malang, East Java, Indonesia

Site Status

Countries

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Indonesia

References

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Dinh QN, Drummond GR, Sobey CG, Chrissobolis S. Roles of inflammation, oxidative stress, and vascular dysfunction in hypertension. Biomed Res Int. 2014;2014:406960. doi: 10.1155/2014/406960. Epub 2014 Jul 20.

Reference Type RESULT
PMID: 25136585 (View on PubMed)

Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.

Reference Type RESULT
PMID: 26131326 (View on PubMed)

Related Links

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https://austinpublishinggroup.com/cardiovascular-diseases/fulltext/ajcd-v3-id1017.php

Journal Title: Vascular Inflammation and Hypertension

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjt-4mj36_zAhUS5nMBHaFQCYsQFnoECAkQAQ&url=https%3A%2F%2Fcare.diabetesjournals.org%2Fcontent%2Fdiacare%2Fsuppl%2F2016%2F12%2F15%2F40.Supplement_1.DC1%2FDC_40_S1_final.pdf&usg=AOvVaw0Qzl4wVSDwGETFGIa99gJB

Standards of Medical Care in Diabetes

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjt_eG636_zAhVj5nMBHZexBdkQFnoECAkQAQ&url=https%3A%2F%2Fwww.longdom.org%2Fopen-access%2Fclassification-pathophysiology-diagnosis-and-management-of-diabetesmellitus-2155-6156-1000541.pdf&usg=AOvVaw3TEJc1UhMPP5_lZDYF-Y1z

Journal Title: Pathophysiology, Diagnosis and Management of Diabetes Melitus

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi5lYHY36_zAhWtuksFHUGjCH8QFnoECAMQAQ&url=https%3A%2F%2Fwww.iomcworld.org%2Fopen-access%2Fhypertension-pathophysiology-and-treatment-2155-9562-5-1000250.pdf&usg=AOvVaw2rNOEbO3b_BS9WrpNQHWVx

Journal Title: Hypertension: Pathophysiology and Treatment

https://www.cdc.gov/mmwr/volumes/65/wr/mm6545a3.htm

CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension

Other Identifiers

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MFBU.DS.PsP021

Identifier Type: -

Identifier Source: org_study_id