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Outcome Measures

Primary Outcomes (1)

Change in Quality of Life from completion of SF-36 questionnaire
Quality of Life is assessed by Indonesia validated Short Formm 36 questionnaire. This questionnaire consist of 36 items/questions that evaluate quality of life in some elements. The elements are consisted of changes in health (1 item), general health perception (5 items), energy/fatique (4 items), mental health (5 items), social functioning (2 items), pain (2 items), physical functioning (10 items), role limitations due to emotional problems (3 items) and role limitations due to physical problems (4 items). The score from each question will be summed. Minimum score is 36 and maximum score is 138. Higher score indicates higher quality of life and lower score indicates lower quality of life. Higher score after intervention in post-test examination represents a positive outcome
0 and 90 days

Secondary Outcomes (17)

Change of inflammation status parameter (IL-6) level
0 and 90 days
Change of inflammation status parameter (TNF-alpha) level
0 and 90 days
Change of inflammation status parameter (hs-CRP) level
0 and 90 days
Change of oxidative stress parameter (MDA) level
0 and 90 days
Change of oxidative stress parameter (SOD) level
0 and 90 days
+12 more secondary outcomes

Other Outcomes (2)

Number of participants with adverse event (AEs)
30, 60, and 90 days
Number of participants with Serious Adverse Event (SAEs)
30, 60, and 90 days

Study Arms (2)

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

EXPERIMENTAL

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

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

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo Group

Interventions

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

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

Also known as: β-1,3/1,6-D-Glucan

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

Placebo GroupDrug

Takes placebo capsule 3 times daily for 90 days

Related Publications (2)

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.

PMID: 25136585RESULT

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.

PMID: 26131326RESULT

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

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.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Prof, Ph.d, MD

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Other Outcomes (2)

Study Arms (2)

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

Placebo Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Other Outcomes (2)

Study Arms (2)

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

Placebo Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations