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 Based on NCEP-ATP III Criteria With Modification on Obesity Classification (Waist Circumference Measurement) for Asian Population
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Quality of Life from completion of SF-36 questionnaire
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group (Drug)
Placebo Group
This group will receive empty capsule which will be taken 3 times daily for 90 days
干预措施: Placebo Group (Drug)
结局指标
主要结局
Change in Quality of Life from completion of SF-36 questionnaire
时间窗: 0 and 90 days
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
次要结局
- Change of total cholesterol level status(0 and 90 days)
- Change of inflammation status parameter (TNF-alpha) level(0 and 90 days)
- Change of body weight and body height measurement(0 and 90 days)
- Change of creatinine blood level(0 and 90 days)
- Change of endothelial function (NO) parameter level(0 and 90 days)
- Change of fasting glucose level(0 and 90 days)
- Change of HbA1C serum level(0 and 90 days)
- Change of urea blood level(0 and 90 days)
- Change of oxidative stress parameter (SOD) level(0 and 90 days)
- Change of inflammation status parameter (IL-6) level(0 and 90 days)
- Change of inflammation status parameter (hs-CRP) level(0 and 90 days)
- Change of waist circumference measurement(0 and 90 days)
- Change of triglicyride level status(0 and 90 days)
- Change of oxidative stress parameter (MDA) level(0 and 90 days)
- Change of blood pressure(0 and 90 days)
- Change of HDL level status(0 and 90 days)
- Change of LDL level status(0 and 90 days)
研究者
Prof. Dr. dr. Djanggan Sargowo, Sp.PD, Sp.JP(K)
Prof, Ph.d, MD
University of Brawijaya