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| Name | Class |
|---|---|
| PT. Sahabat Lingkungan Hidup | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo Group | Placebo Comparator | This group will receive empty capsule which will be taken 3 times daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of inflammation status parameter (IL-6) level | Level of IL-6 is obtained from laboratory blood plasma test | 0 and 90 days |
| Change of inflammation status parameter (TNF-alpha) level | Level of TNF-alpha is obtained from laboratory blood plasma test |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse event (AEs) | Number of participants that experience adverse event in this study | 30, 60, and 90 days |
| Number of participants with Serious Adverse Event (SAEs) | Number of participants that go through serious adverse event in this study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Brawijaya University (Rumah Sakit Universitas Brawijaya) | Malang | East Java | 65141 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25136585 | Result | 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. | |
| 26131326 | 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. |
| Label | URL |
|---|---|
| Journal Title: Vascular Inflammation and Hypertension | View source |
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The research team would like to discuss to what extent and the criteria of individual participant data that will be shared related to Statistical Analysis Plan, Informed Consent Form and/or Clinical Study Report
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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.
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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.
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| Placebo Group | Drug | Takes placebo capsule 3 times daily for 90 days |
|
| 0 and 90 days |
| Change of inflammation status parameter (hs-CRP) level | Level of hs-CRP is obtained from laboratory blood plasma test | 0 and 90 days |
| Change of oxidative stress parameter (MDA) level | Level of MDA is obtained from laboratory blood plasma test | 0 and 90 days |
| Change of oxidative stress parameter (SOD) level | Level of SOD is obtained from laboratory blood plasma test | 0 and 90 days |
| Change of endothelial function (NO) parameter level | Level of NO is obtained from laboratory blood plasma test | 0 and 90 days |
| Change of waist circumference measurement | Waist circumference is measured by tape to determine abdominal obesity | 0 and 90 days |
| Change of body weight and body height measurement | Body weight is measured by body weight scale and body height is measured by body height scale, then will be combined to determine BMI in kg/m^2 | 0 and 90 days |
| Change of blood pressure | Blood pressure is measured using manual sphygmomanometer | 0 and 90 days |
| Change of fasting glucose level | Fasting glucose level is obtained from laboratory blood test | 0 and 90 days |
| Change of HbA1C serum level | HbA1C serum level is obtained from laboratory blood test | 0 and 90 days |
| Change of triglicyride level status | Triglyceride level is obtained from laboratory blood test | 0 and 90 days |
| Change of total cholesterol level status | Total cholesterol level is obtained from laboratory blood test | 0 and 90 days |
| Change of HDL level status | HDL level is obtained from laboratory blood test | 0 and 90 days |
| Change of LDL level status | LDL level is obtained from laboratory blood test | 0 and 90 days |
| Change of creatinine blood level | Creatinine level is obtained from laboratory blood test | 0 and 90 days |
| Change of urea blood level | Urea level is obtained from laboratory blood test | 0 and 90 days |
| 30, 60, and 90 days |
| Standards of Medical Care in Diabetes | View source |
| Journal Title: Pathophysiology, Diagnosis and Management of Diabetes Melitus | View source |
| Journal Title: Hypertension: Pathophysiology and Treatment | View source |
| CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension | View source |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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