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COMPLETED
NCT07821853
PHASE2

N-Acetylcysteine in Patients With Leptospirosis

Sponsor: Dr Cipto Mangunkusumo General Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether oral N-acetylcysteine (NAC) can reduce markers of kidney tubular injury, oxidative stress, and inflammation in adults with non-severe leptospirosis. The main questions it aims to answer are: * Does NAC result in a greater reduction in urinary kidney injury molecule-1 (KIM-1) levels from Day 1 to Day 5 compared with placebo? * Does NAC result in a greater reduction in serum reactive oxygen species (ROS) and C-reactive protein (CRP) levels from Day 1 to Day 5 compared with placebo? Researchers will compare NAC with a placebo to determine whether NAC produces greater changes in these biomarkers. Participants will: * Receive oral NAC 800 mg three times daily or a matching placebo for five days in addition to standard treatment for leptospirosis. * Have urinary KIM-1, serum ROS, and CRP measured before treatment and on Day 5.

Official title: Efek N-Acetylcysteine Terhadap Cedera Tubulus Ginjal, Stres Oksidatif, Dan Inflamasi Pada Pasien Leptospirosis Non-Severe: Sebuah Uji Klinis Acak Tersamar Ganda

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-08-30

Completion Date

2026-04-26

Last Updated

2026-09-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

N-acetylcysteine

Participants received oral N-acetylcysteine 800 mg three times daily for 5 consecutive days.

DRUG

Placebo

Participants received an oral matching placebo three times daily for 5 consecutive days.

Locations (1)

RSUD Balaraja

Tangerang, Banten, Indonesia