Background: Tinnitus is defined as the perception of sound in the ear or head in the absence of an external stimulus for which we have no definite treatment. Neurotec is a medication of herbal origin with IFDA approval. Previous studies showed the neuroprotective effect of Neurotec. In this study, we evaluated the effectiveness of Neurotec in improving tinnitus symptoms. Methods: This double-blind randomized clinical trial was performed on patients with tinnitus. Patients received Neurotec 100 mg capsules (BID) or placebo for three months. Pure tone audiometry (PTA) was measured at 0.5, 1, 2, 4, and 6 kHz frequencies. Using a Tinnitus Handicap Inventory (THI) questionnaire, tinnitus loudness, daily annoyance, daily life or sleep disturbance, daily perception, and mood alteration were evaluated. Results: Finally, 103 (69 male and 34 female) patients with a mean age of 51.33 13.91 years were analyzed. There was no significant difference between the intervention (n=53) and the control group (n=50) regarding baseline symptoms before and one month after the intervention (P>0.05). While they were significantly different three months after the intervention (P<0.05). The mean pure-tone air and bone conduction were not significantly different between the control and the intervention group before and three months after the intervention at 0.5,1,2 and 4 kHz (P>0.05). The mean pure-tone air conduction was not significantly different between the two groups before and three months after the intervention at 6 kHz (P>0.05). Conclusion: A three-month treatment with Neurotec Capsules beside patient education can effectively control symptoms of patients with tinnitus.

The authors have declared no competing interest.

IRCT2017042817413N23

This study was funded by Baqiyatallah University of Medical Sciences

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This study was approved by the ethics committee of Baqiyatallah University of Medical Sciences (Ref. No: IR.BMSU.REC.1395.176) and Iranian Registry of Clinical Trials (Ref. No: IRCT2017042817413N23),

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