Randomized, Placebo-Controlled Trial of N-acetylcysteine In Parkinson's Disease Patients: A Pilot Study

Not Applicable

Completed

• Conditions: Parkinson's Disease (PD)
• Interventions: Drug: Placebo; Drug: N-Acetylcysteine (NAC) Treatment

• Registration Number: NCT07093944
• Lead Sponsor: Kurdistan University of Medical Sciences

Brief Summary

This is a study on Parkinson's disease patients, referred to Tohid Hospital of Sanandaj City. The patients receive N-acetylcysteine for one year. The efficacy of the Drug is evaluated based on clinical interview, filling Unified Parkinson's Disease Rating Scale (UPDRS) questionnaire, and single-photon emission computerized tomography (SPECT) brain imaging. The only person who has not been blinded for the study is the supplier of the drug and placebo.

Inclusion criteria: Patient's informed consent Exclusion criteria: Having brain surgery within a year before the initiation of the intervention.

Medication group: receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg.

placebo group: receiving a placebo with similar appearance, color, odor, and taste like real medication.

Detailed Description

This is a randomized double-blinded clinical trial. Randomization method is based on making blocks with size of 4 people, to divide participants into two groups: intervention group (A) and control group (B). So that, we divide all participants to four-sample blocks, and we allocate the block's samples equally between the two groups (e.g. ABAB). This pattern is the same in all blocks. Participants, clinical caregivers, outcome evaluators and data analyzers are not aware whether the therapeutic regimens include the drug or placebo. only the main researcher and pharmacist are aware of nature of therapeutic regimen based on codes given to the drug and placebo packages, earlier.

Study Timeline

• Study Start: 2018-04-09
• Primary Completion: 2021-12-22
• Study Completion: 2021-12-22
• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patient's informed consent No brain surgery in the patient's post medical history

Exclusion Criteria

• having brain surgery within a year before starting the treatment period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Receiving a placebo with similar appearance, color, odor, and taste like real medication
Medication group	N-Acetylcysteine (NAC) Treatment	Receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)	one year for each PD patient (at baseline and after one year)	It is a questionnaire to assess the severity and progression of Parkinson's disease.
single-photon emission computerized tomography (SPECT) brain imaging	one year	Also known as TRODAT scan or DaTscan, is a nuclear medicine imaging procedure that helps diagnose and evaluate Parkinson's disease by assessing the function of dopamine transporters in the brain. It specifically visualizes the dopaminergic system, which is affected in Parkinson's disease.

Trial Locations

Locations (1)

Kurdistan University of Medical Sciences; 🇮🇷 Sanandaj, Kurdistan, Iran, Islamic Republic of