This study is designed as a randomized, double-blind, placebo-controlled trial. To prevent bias and ensure the integrity of the study, the following groups will be blinded to the treatment allocation:
Trial Participants: Patients will be completely unaware of their assigned group. Both the active medication (Azithromycin 500 mg) and the placebo (a cornstarch-based formulation manufactured by Exir Pharmaceutical Company) are visually identical in shape, size, and color. The medications will be provided to participants in sealed, opaque, and identically coded envelopes without any identifying labels.
Principal Investigator and Healthcare Providers: The treating physicians and healthcare staff responsible for enrolling patients, providing routine care, and dispensing the study packages will be blinded to the allocation sequence. They will only have access to the predefined random codes on the envelopes.
Data Collectors and Outcome Assessors: The researchers responsible for clinical evaluations, calculating disease activity scores, and recording patient data will remain blinded to the treatment assignment to ensure unbiased clinical assessments.
Mechanism of Blinding: An independent third-party researcher, who has no role in patient recruitment, clinical care, or outcome assessment, will be exclusively responsible for generating the allocation sequence, preparing the identical drug/placebo packages, and labeling them with random codes. This independent individual will keep the master blinding code secure and confidential until the data collection phase is fully completed and the database is locked for analysis.