» Advanced search
Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
 
{{ selectedCountPage }} items selected on this page, {{ selectedCountPage }} item selected on this page, {{ selectedCountTotal }} item in total {{ selectedCountTotal }} items in total
Study aim: To evaluate the efficacy of oral royal jelly in reducing tinnitus severity in patients diagnosed with subjective tinnitus. Design: This is a randomized, double-blind, placebo-controlled, parallel-group phase II clinical trial. A total of 60 participants (30 per group) will be enrolled. Randomization will be performed using block randomization (blocks of four) with the Rand function in Microsoft Excel. Settings and conduct: The study will be conducted in 2025 at Al-Zahra Hospital in Isfahan and Ayatollah Kashani Hospital in Kashan. Both participants and assessors will be blinded. Syrups will be packaged identically and labeled with anonymized codes. Participants will be assessed at baseline and at 3, 6, and 12 weeks after the intervention. Participants/Inclusion and exclusion criteria: Inclusion criteria: confirmed diagnosis of tinnitus by an ENT specialist, no prior history of hypersensitivity to royal jelly, absence of psychiatric disorders, and no history of hearing aid use or ototoxic medications. Exclusion criteria: unwillingness to continue participation, hypersensitivity to royal jelly, irregular medication use, concurrent use of other therapeutic strategies, and presence of acoustic neuroma or other organic auditory nerve lesions. Intervention groups: The intervention group will receive oral royal jelly syrup daily for 30 days. The control group will receive a placebo syrup matched in color, taste, and viscosity without the active ingredient. Main outcome variables: Tinnitus severity measured using the Tinnitus Handicap Inventory (THI) at weeks 0, 3, 6, and 12; changes in THI score from baseline.
IRCTID: IRCT20240327061371N3
Loading...