A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with mild cognitive impairment and Tinnitus as compared to a placebo. Approximately 112 individuals aged between 30 and 75years will be screened. Considering a screen failure of 25%, approximately 84 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 64 completed participants i.e. 32 participants in each study arm after accounting for adropout/withdrawal rate of 25% at the end of the study. The intervention and follow up duration for all the study participants will be 90 days.
• Males and females between 30 - 75 years old (both values included).
• Individuals with mild cognitive impairment as indicated by Addenbrooke's Cognitive Examination (ACE) III score between 61 - 82 (both values included).
• Individuals with subjective tinnitus with normal hearing or up to moderate sensorineural hearing loss for more than 6 months' duration.
• Tinnitus maskable with noise of at least 5 decibels assessed by audiometry.
• Individuals with a THI score between 18 to 56 (both values included).
• Progressive cognitive complaints like stress, disturbed sleep etc. reported by participant or caregiver.
• Individuals willing to provide a signed and dated informed consent and authorization to use personal health information in accordance with local and national guidance and regulations.
• Individuals willing to comply with all procedures as outlined in the informed consent.