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

NCT ID: NCT07093944

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2021-12-22

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.

Conditions

Parkinson's Disease (PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Medication group

Receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg

Group Type: EXPERIMENTAL

N-Acetylcysteine (NAC) Treatment

Intervention Type: DRUG

Parkinson's disease patients receive NAC (1200 mg/day) for one year.

Placebo group

Receiving a placebo with similar appearance, color, odor, and taste like real medication

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Parkinson's disease patients receive Placebo similar to the real drug, with no active ingredient

Interventions

N-Acetylcysteine (NAC) Treatment

Parkinson's disease patients receive NAC (1200 mg/day) for one year.

Intervention Type: DRUG

Placebo

Parkinson's disease patients receive Placebo similar to the real drug, with no active ingredient

Intervention Type: DRUG

Other Intervention Names

NAC; Fluimucil effervescent tablet

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kurdistan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Arman Rahimmi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kurdistan University of Medical Sciences

Sanandaj, Kurdistan Province, Iran

Countries

Iran

Other Identifiers

MUKIRAN

Identifier Type: OTHER

Identifier Source: secondary_id

IR.MUK.REC.1397/348

Identifier Type: -

Identifier Source: org_study_id