PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers (NCT07316400) | Clinical Trial Compass
CompletedNot Applicable
PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers
Indonesia200 participantsStarted 2024-09-01
Plain-language summary
The goal of this randomized controlled clinical trial is to evaluate whether polysaccharide peptide (PsP) supplementation from Ganoderma lucidum can modulate biomarkers of oxidative stress, inflammation, nicotine exposure, and stress response in adults exposed to cigarette smoke. The study is conducted in adults aged 20-50 years with active or passive exposure to cigarette smoke.
The main questions it aims to answer are:
* Does PsP supplementation change serum malondialdehyde (MDA) and superoxide dismutase (SOD) levels over 8 weeks?
* Does PsP supplementation affect serum interleukin-6 (IL-6), nitric oxide (NO), cotinine, nicotinic acetylcholine receptor (nAChR), and cortisol levels?
Researchers will compare participants receiving PsP supplementation with those receiving a placebo to evaluate differences in changes in the specified biomarkers.
Participants will:
* Be randomly assigned to receive PsP capsules (500 mg/day) or placebo for 8 weeks
* Provide fasting blood samples at baseline and at the end of the intervention
* Maintain usual lifestyle habits while avoiding antioxidant supplements during the study period
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female adults aged 18 to 60 years.
. Has smoked regularly for at least the past 12 months.
. Able and willing to provide written informed consent.
. Agrees to maintain usual smoking habits during the study period.
. Able to comply with study procedures and visits.
Exclusion criteria
. Current use of antioxidant supplements, vitamins, herbal supplements, or mushroom- derived products within the last 4 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.