A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment
NCT ID: NCT06859346
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
84 participants
INTERVENTIONAL
2025-04-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors
NCT05472285
To Access the Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour.
NCT03198936
Efficacy of MEMORMAX in Subjects With MCI
NCT03581929
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
NCT01160692
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
NCT03780621
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: TisinaTM complex
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Arm 1: TisinaTM complex
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Arm 2: Placebo (Microcrystalline Cellulose)
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Arm 2: Placebo (Microcrystalline Cellulose)
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arm 1: TisinaTM complex
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Arm 2: Placebo (Microcrystalline Cellulose)
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
30 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aster Adhar Hospital
Kolhāpur, Maharashtra, India
Dr.Selvan's homeopathy
Mumbai, Maharashtra, India
Omkar ENT Hopital
Nashik, Maharashtra, India
Moraya Multispeciality Hospital,
Pune, Maharashtra, India
Silver brich multispeciality hospital
Pune, Maharashtra, India
Dr.D Y Patil medical college hospital & Research Center
Thāne, Maharashtra, India
Jaipur National University
Jaipur, Rajasthan, India
Subharti Medical College and Hospital
Meerut, Uttar Pradesh, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCH/240702/IP/MCI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.