Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05300594
Brief Summary:
Tinnitus is a widespread problem that affects the quality of life of millions globally.
Few treatments have been found to be effective for subjective tinnitus and to have a significant improvement on quality of life. In subjective tinnitus, neither an external nor endogenous sound source is present; instead, the tinnitus is caused by abnormal bioelectric, biomechanical, or biochemical activity in the inner ear and/or central nervous system.
The precise role of the numerous extra-auditory structures that contribute to the pathophysiology of tinnitus is difficult to establish. Some of them participate in the creation or in the chronification of tinnitus and some in the psychological reactions to the tinnitus.
Audistim contains ingredients with a specific composition based upon the multifactorial causal theory; which involves auditory, attentional, memory, and emotional systems. These different systems are being targeted by the ingredients and their specific proportioning. Also the antioxidant theory is involved in the creation of Audistim, it states that the reactive oxygen species play an important microcirculatory role in the pathology of the inner ear and the peripheral and central pathways. These components help to treat the multitude of causing factors and in that way improve the quality of life.
Detailed Description:
Participants are allocated in test (dietary supplement) or placebo group according a ratio 1:1.
The participants are asked to consume daily the investigational product for 3 months. The effect of the dietary supplement is assessed by comparing chronic tinnitus evolvement between groups.
Study:
NCT05300594
Study Brief:
Protocol Section:
NCT05300594