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

NCT05079529 | Unknown Phase 2

• 1 other identifier: MFBU.DS.PsP021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiometabolic Syndrome

Keywords

β-1,3/1,6-D-Glucan; Polysaccharide Peptide; Ganoderma lucidum; Cardiometabolic syndrome

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

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 Group DRUG

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 Group DRUG

Takes placebo capsule 3 times daily for 90 days

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Brawijaya: lead
• PT. Sahabat Lingkungan Hidup: collaborator

Study Sites (1)

General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya)

Malang, East Java, 65141, Indonesia

Location

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: 25136585 RESULT

• 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: 26131326 RESULT

Related Links

• Journal Title: Vascular Inflammation and Hypertension
• Standards of Medical Care in Diabetes
• Journal Title: Pathophysiology, Diagnosis and Management of Diabetes Melitus
• Journal Title: Hypertension: Pathophysiology and Treatment
• CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, Ph.d, MD

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.

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 15, 2021
• Study Start: June 30, 2021
• Primary Completion: December 28, 2021
• Study Completion: January 6, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

ID (1)