A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment

Inclusion criteria

• 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.

Exclusion criteria

• Individuals with a medical history of heart disease, respiratory disorders, seizure disorders, metabolic syndrome or other chronic health conditions requiring medication.
• Clinically diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD)
• Clinically diagnosed with Alzheimer's disease.
• Individuals with clinically significant psychiatric or neurological states, neurodegenerative disorders such as Parkinson's disease & fronto-temporal dementia, etc, that may account for cognitive impairment.
• Individuals of objective (pulsatile) tinnitus.
• Individuals suffering with any congenital anomalies which may lead to any otological problem.
• Individuals suffering from any infective otological problem.
• Individuals suffering from any otological problem other than tinnitus and sensorineural hearing.
• Individuals whose tinnitus resulted from acute acoustic trauma, sudden deafness or traumatic head or neck injury.
• Individuals taking any ototoxic or potentially tinnitus-inducing medication (e.g., aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin or quinine).
• Individuals with Meniere's disease, otosclerosis and acute or chronic otitis media.
• Individuals with history and/or presence significant gastrointestinal disease, active malignant diseases, autoimmune diseases, haemorrhagic diathesis, cardiovascular, renal or hepatic disorders, psychiatric disorders, thyroid disease or any other acute or chronic disease.
• Individuals who are not willing to maintain their medication, diet or physical activity habits during the study.
• Individuals with uncontrolled Hypertension with systolic blood pressure more than or equal to 140 and/or diastolic blood pressure more than or equal to 90 mm Hg.
• Individuals with FBG more than or equal to 126 mg/dl.
• Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) values exceeding 2 times the upper normal limit.
• Serum creatinine levels exceeding 1.5 times the upper normal limit.
• Head injury immediately preceding cognitive deterioration.
• History of uncontrolled migraine headaches, severe sleep disorders.
• Use of psychotropic drugs or any other drug or supplement such as nootropics that may significantly affect cognitive functioning during the month prior to psychometric testing.
• Use of any experimental medication or OTC medication or herbal treatment such as hesperidin, diosmin and other flavonoids within 1 month prior to screening.
• Females taking any oral contraceptives.
• Current smokers.
• Consumption of excessive amount of caffeine i.e. ≥ 4 cups daily (> 500 mg per day).
• History of drug, substance or alcohol addiction or abuse within the past 12 months.
• Prior participation in a clinical study in the past 90 days before screening.
• Females who are pregnant/planning to be pregnant or currently lactating.