CompletedNot Applicable

Effect of Hydroxytyrosol on NLR, MLR, and SOD in Hypertensive Pregnant Women

Indonesia42 participantsStarted 2025-07-10

Plain-language summary

The goal of this clinical trial is to evaluate whether hydroxytyrosol supplementation (10 mg/day for 4 weeks) is effective in improving inflammatory and oxidative stress markers in pregnant women diagnosed with hypertensive disorders of pregnancy (including preeclampsia, chronic hypertension, and gestational hypertension). The main questions it aims to answer are: 1. Does hydroxytyrosol supplementation reduce neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR)? 2. Does hydroxytyrosol supplementation lower systolic and/or diastolic blood pressure? 3. Does hydroxytyrosol supplementation increase superoxide dismutase (SOD) levels? Researchers will compare a group receiving hydroxytyrosol supplementation to a standard care control group to see if hydroxytyrosol produces superior anti-inflammatory and antioxidant effects. Participants will: * Take hydroxytyrosol 10 mg orally once daily for 4 weeks (intervention group) or receive standard antenatal care without hydroxytyrosol (control group). * Undergo laboratory testing (NLR, MLR, SOD) before and after the intervention. * Have their blood pressure monitored regularly throughout the study period.

Who can participate

Age range

24 Years – 45 Years

Sex

FEMALE

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

. Singleton pregnancy with a live intrauterine fetus
. Gestational age over 24 weeks. Gestational age is confirmed based on:
. Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:

Exclusion criteria

. Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B
. Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
. Refusal to participate in the study

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

Change in Neutrophil-to-Lymphocyte Ratio (NLR), MLR (Monocyte-to-Lymphocyte Ratio), and SOD (Superoxide Dismutase level) from Baseline to Week 4

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT07074548

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Hypertension in Pregnancy trials