Can a supplement boost brain health in mild cognitive impairment?
NCT ID NCT06859346
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed clinical trial tested whether a dietary supplement called Tisina complex could improve cognitive health in people with mild cognitive impairment and tinnitus. About 84 adults aged 30 to 75 took either the supplement or a placebo for 90 days. Researchers measured changes in memory, attention, and other thinking skills using standard tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tisina complex (dietary supplement)
- What this could lead to
- If it works, this could point toward a supplement that helps with memory and thinking in people with mild cognitive impairment.
- What could go wrong
- This is a small, early-stage trial with only 84 participants, and the results are not yet published. Dietary supplements often show limited benefits in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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84 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Cognitive Examination (ACE) III score between 61 - 82 (both values included). 3. Individuals with subjective tinnitus with normal hearing or up to moderate sensorineural 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 by participant or caregiver. 7. 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. 8. Individuals willing to comply with all procedures as outlined in the informed consent. EXCLUSION CRITERIA: 1. Individuals with a medical history of heart disease, respiratory disorders, seizure disorders, metabolic syndrome or other chronic health conditions requiring medication. 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 otological problem. 7. Individuals suffering from any infective otological problem. 8. Individuals suffering from any otological problem other than tinnitus and sensorineural hearing. 9. Individuals whose tinnitus resulted from acute acoustic trauma, sudden deafness or traumatic head or neck injury. 10. Individuals taking any ototoxic or potentially tinnitus-inducing medication (e.g., aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin or quinine). 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 disease or any other acute or chronic disease. 13. Individuals who are not willing to maintain their medication, diet or physical activity habits during the study. 14. 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. 15. Individuals with FBG more than or equal to 126 mg/dl. 16. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) values exceeding 2 times 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 that may significantly affect cognitive functioning during the month prior to psychometric testing. 21. Use of any experimental medication or OTC medication or herbal treatment such as hesperidin, 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aster Adhar Hospital
Kolhāpur, Maharashtra, 416012, India
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Dr.D Y Patil medical college hospital & Research Center
Thane, Maharashtra, 400706, India
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Dr.Selvan's homeopathy
Mumbai, Maharashtra, 400017, India
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Jaipur National University
Jaipur, Rajasthan, 302017, India
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Moraya Multispeciality Hospital,
Pune, Maharashtra, 411033, India
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Omkar ENT Hopital
Nashik, Maharashtra, 422002, India
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Silver brich multispeciality hospital
Pune, Maharashtra, 411041, India
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Subharti Medical College and Hospital
Meerut, Uttar Pradesh, 250005, India
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