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IRCT20240327061371N3 IRCT 2025-05-26 Esfahan University of Medical Sciences Studying the effect of royal jelly on the treatment of tinnitus Evaluating the Efficacy of Royal Jelly Compared to Placebo in Improving Tinnitus in Affected Patients: Randomized controlled trial 2025-05-31 anticipated 60 Complete https://irct.ir/trial/83445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were assessed for tinnitus severity before treatment and at 1, 3, 6, and 12 weeks after treatment using the THI questionnaire, Randomization description: To ensure equal distribution of patients to the treatment and placebo groups and to maintain balance during the randomization process, a block randomization method will be used. The block size is chosen as 4, which is a multiple of the number of groups. For a block of four, the combinations AABB, ABAB, ABBA, BBAA, BABA, BAAB will be defined. The order of the blocks will be randomized using Excel software. Fifteen blocks will be required to allocate 60 patients (30 in each group).These 15 blocks are randomly selected and will be repeated as needed. Patients are then assigned sequentially based on the random order of the blocks. For example, the first four patients are assigned according to the first block allocation, the next four patients according to the second block, and so on until all 60 patients are assigned, Blinding description: To ensure a double-blind study, both patients and investigators will be unaware of group assignments (royal jelly or placebo). Group A will receive 10 cc of royal jelly syrup daily for 30 days. Group B will receive 10 cc of placebo syrup following the same schedule. The placebo syrup is formulated to match the active drug in color, odor, and viscosity, and contains distilled water as the base, sucrose as a sweetener, flavoring, food coloring, and, if necessary, an approved preservative (e.g., sodium benzoate). The placebo formulation and preparation will be conducted by a specialized pharmacist in compliance with Good Manufacturing Practice (GMP) standards. The placebo syrup will be packaged and labeled in containers and boxes identical to those of the active drug and coded by an independent pharmacist. The code key will remain with the pharmacist until the study’s completion to prevent bias. 2 Tinnitus. Intervention 1: Intervention group: Participants in this group will receive an oral syrup containing royal jelly once daily for 30 consecutive days. Each dose consists of 10 milliliters of syrup per day. The formulation includes pure royal jelly as the active ingredient, distilled water, an oral sweetener (such as sucrose), and approved edible flavoring and coloring agents. The syrup will be manufactured under GMP conditions and packaged identically to the placebo to maintain double-blinding. The detailed composition and preparation process will be supervised and verified by the study pharmacist. Intervention 2: Control group: Participants in this group will receive a placebo syrup once daily for 30 days. The placebo formulation consists of distilled water, an oral sweetener (such as sucrose), edible coloring and flavoring agents to match the taste, color, and viscosity of the active syrup. The placebo will be prepared under Good Manufacturing Practice (GMP) standards and packaged identically to the active product to ensure blinding. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision on sharing individual-level raw data will be made later considering ethical concerns and data privacy protection.
public Afrooz Eshaghian
Kashani St, Kashani hospital, otolaryngology head and neck surgery department
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3233 0092 afroozeshaghian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Afrooz Eshaghian
Kashani St, Kashani hospital, otolaryngology head and neck surgery department
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3233 0092 afroozeshaghian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Tinnitus and confirmation of the condition based on clinical diagnosis by an otolaryngologist and based on audiometry results (audiometry including tinnitus frequency) No history of allergy to royal jelly. No history of mental disorders or use of stimulant medications Not having hearing loss or deafness or using hearing aids Avoid taking ototoxic medications. no limit no limit Both Concomitant use of other treatment strategies Unwillingness to participate in the study Allergy to royal jelly Organic causes, if diagnosed, such as Meniere's disease and acoustic neuroma Unilateral Tinnitus H93.1 Tinnitus Treatment - Drugs Placebo Intervention group: Participants in this group will receive an oral syrup containing royal jelly once daily for 30 consecutive days. Each dose consists of 10 milliliters of syrup per day. The formulation includes pure royal jelly as the active ingredient, distilled water, an oral sweetener (such as sucrose), and approved edible flavoring and coloring agents. The syrup will be manufactured under GMP conditions and packaged identically to the placebo to maintain double-blinding. The detailed composition and preparation process will be supervised and verified by the study pharmacist. Control group: Participants in this group will receive a placebo syrup once daily for 30 days. The placebo formulation consists of distilled water, an oral sweetener (such as sucrose), edible coloring and flavoring agents to match the taste, color, and viscosity of the active syrup. The placebo will be prepared under Good Manufacturing Practice (GMP) standards and packaged identically to the active product to ensure blinding. Tinnitus severity based on the total score of the “Tinnitus Handicap Inventory” questionnaire, which assesses the impact of tinnitus on patients’ daily life. Timepoint: Tinnitus severity score will be measured at baseline (before the intervention) and at weeks 1, 3, 6, and 12 after the start of royal jelly syrup consumption. Method of measurement: Tinnitus severity will be assessed using the validated Persian version of the “Tinnitus Handicap Inventory” questionnaire, consisting of 25 questions rated on a five-point Likert scale. Esfahan University of Medical Sciences Approved 2025-05-11 Ethics Committee of Isfahan University of Medical Sciences Building No. 4, Hezar Jarib Street, Isfahan University of Medical Sciences and Health Services, Vice-Chancellery for Research and Technology Isfahan Isfehan Iran (Islamic Republic of)