NCT07298759: HYDROXY-2

The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial

Active, enrolled NA Last updated 6 January 2026

What this trial tests

NA trial testing Placebo in Hypertension in Pregnancy in 52 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 June 2025

Primary endpoint
31 December 2025

1 February 2026

Quick facts

Lead sponsor	Dr Cipto Mangunkusumo General Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	52
Start date	11 June 2025
Primary completion	31 December 2025
Estimated completion	1 February 2026
Sites	1 location across Indonesia

Drugs / interventions tested

• Placebo
• Hydroxytyrosol — full drug profile →

Conditions studied

• Hypertension in Pregnancy — all drugs for Hypertension in Pregnancy →

Sponsor

Dr Cipto Mangunkusumo General Hospital

Who can join

Eligibility, female only, with Hypertension in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4.
  Time frame: Baseline and Week 4
  To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in superoxide dismutase (SOD) between the hydroxytyrosol and placebo groups after 4 weeks. This examination utilizes blood serum as the test specimen. The reagent kit employed is the Superoxide Dismutase (SOD) Colorimetric Assay Kit (Zellbio GmbH, Germany; Cat: ZX-44108-192, Lot: ZX25003G). Measurem
• Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4.
  Time frame: Baseline and Week 4
  To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Pulsatility Index (PI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks. All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to
• Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4.
  Time frame: Baseline and Week 4
  To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Resistance Index (RI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks. All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to o
• Change in flow-mediated dilation (FMD) of brachial artery measured by an ultrasound from baseline to week 4.
  Time frame: Baseline and Week 4
  To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in flow-mediated dilation (FMD) of brachial artery between the hydroxytyrosol and placebo groups after 4 weeks. All FMD of brachial artery examinations are using a GE Voluson P6 ultrasound machine equipped with a 5-13 MHz transducer, and performed by a single operator.

Sponsor's own description

The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation.

Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.