CompletedPhase 2

Effect of Alpha Tocopherol and Psyllium on Lipid Levels in Dyslipidaemia Patients

Pakistan60 participantsStarted 2022-06-15

Plain-language summary

The goal of this clinical trial is to find out whether Vitamin E (Alpha tocopherol), taken alone or together with Psyllium husk (a type of dietary fibre), can improve blood fat levels in adults with dyslipidaemia (abnormal blood levels of two types of fat: cholesterol and triglycerides). The main questions this study aims to answer are: * Does Vitamin E (400 mg/day) alone help lower blood cholesterol and triglyceride levels? * Does combining Vitamin E (400 mg/day) with Psyllium husk (10 g/day) lead to better results compared to participants taking Vitamin E alone? Researchers will compare all three groups i.e. Group A taking Vitamin E alone, Group B taking Vitamin E and Psyllium husk and Group C receiving a placebo (a look alike supplement). The hypothesis of the study is that 'There is a noticeable difference between all the three study groups.' Participants will: * Take their assigned (specific to the concerned group under study) treatment daily for 60 days. * Visit study place every two weeks for follow-up. * Have blood tests done at the beginning and end of the study to check for changes in cholesterol and triglyceride levels.

Who can participate

Age range

40 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: * Participants' age is between 40 to 60 years * Total cholesterol ≥200 mg/dL and * Triglycerides ≥150 mg/dL * Not receiving lipid-lowering therapy Exclusion Criteria: Participants were excluded from the study if they: * Had any other non-communicable disease (e.g. uncontrolled diabetes, cardiovascular disease, or chronic kidney disease) * Were using statins, fibrates, beta-blockers, or antioxidant supplements * Had Familial hyperlipidemia

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.

What they're measuring

Changes in serum cholesterol and serum triglycerides

Timeframe: From baseline (Day 0) to Day 60

Trial details

NCT IDNCT07610304

SponsorNUR International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-15

View on ClinicalTrials.gov More Dyslipidaemia trials