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

INCLUSION CRITERIA:

1. Males and females between 30 - 75 years old (both values included).

2. Individuals with mild cognitive impairment as indicated by Addenbrooke's CognitiveExamination (ACE) III score between 61 - 82 (both values included).

3. Individuals with subjective tinnitus with normal hearing or up to moderatesensorineural hearing loss for more than 6 months' duration.

4. Tinnitus maskable with noise of at least 5 decibels assessed by audiometry.

5. Individuals with a THI score between 18 to 56 (both values included).

6. Progressive cognitive complaints like stress, disturbed sleep etc. reported byparticipant or caregiver.

7. Individuals willing to provide a signed and dated informed consent and authorizationto use personal health information in accordance with local and national guidanceand regulations.

8. Individuals willing to comply with all procedures as outlined in the informedconsent.

EXCLUSION CRITERIA:

1. Individuals with a medical history of heart disease, respiratory disorders, seizuredisorders, metabolic syndrome or other chronic health conditions requiringmedication.

2. Clinically diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD)

3. Clinically diagnosed with Alzheimer's disease.

4. 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.

5. Individuals of objective (pulsatile) tinnitus.

6. Individuals suffering with any congenital anomalies which may lead to any otologicalproblem.

7. Individuals suffering from any infective otological problem.

8. Individuals suffering from any otological problem other than tinnitus andsensorineural hearing.

9. Individuals whose tinnitus resulted from acute acoustic trauma, sudden deafness ortraumatic head or neck injury.

10. Individuals taking any ototoxic or potentially tinnitus-inducing medication (e.g.,aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin orquinine).

11. Individuals with Meniere's disease, otosclerosis and acute or chronic otitis media.

12. Individuals with history and/or presence significant gastrointestinal disease,active malignant diseases, autoimmune diseases, haemorrhagic diathesis,cardiovascular, renal or hepatic disorders, psychiatric disorders, thyroid diseaseor any other acute or chronic disease.

13. Individuals who are not willing to maintain their medication, diet or physicalactivity habits during the study.

14. Individuals with uncontrolled Hypertension with systolic blood pressure more than orequal to 140 and/or diastolic blood pressure more than or equal to 90 mm Hg.

15. Individuals with FBG more than or equal to 126 mg/dl.

16. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) values exceeding 2times the upper normal limit.

17. Serum creatinine levels exceeding 1.5 times the upper normal limit.

18. Head injury immediately preceding cognitive deterioration.

19. History of uncontrolled migraine headaches, severe sleep disorders.

20. Use of psychotropic drugs or any other drug or supplement such as nootropics thatmay significantly affect cognitive functioning during the month prior topsychometric testing.

21. Use of any experimental medication or OTC medication or herbal treatment such ashesperidin, diosmin and other flavonoids within 1 month prior to screening.

22. Females taking any oral contraceptives.

23. Current smokers.

24. Consumption of excessive amount of caffeine i.e. ≥ 4 cups daily (> 500 mg per day).

25. History of drug, substance or alcohol addiction or abuse within the past 12 months.

26. Prior participation in a clinical study in the past 90 days before screening.

27. Females who are pregnant/planning to be pregnant or currently lactating.