2.1. Design overview
DRUG EFFECT
This single-center, randomized, double-blind, placebo-controlled study was conducted between September 2017 and March 2021. We used placebo as a control to evaluate the efficacy and safety of lutein in patients with HM. The main components of the placebo were safflower oil and a stirring agent that had no drug effect. In total, 44 patients were enrolled in the trial in either the intervention or control group (ratio 1:1). All patients were administered the investigational drug or placebo orally, once daily for 6 months, and were interviewed during follow-up visits 3 and 6 months after the initiation of drug administration to complete the efficacy and safety assessments.The study design was approved by the ethics committee of Tokyo Medical and Dental University. All patients were informed of the possible benefits and risks of the study, and provided signed informed consent. This study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments, and the Clinical Trials Act in Japan. This study was registered as a clinical trial in the Japan Registry of Clinical Trials (jRCT; ID: jRCTs031180168).