Cognitive HealthNCT06859346
A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment
A study testing Arm 1: TisinaTM complex in people with Cognitive Health, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Cognitive Health
- What is being tested?
- Arm 1: TisinaTM complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 8 sitesIndia
- Study dates
- 1 Apr 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Jaipur National University
Jaipur, Rajasthan, 302017
Aster Adhar Hospital
Kolhāpur, Maharashtra, 416012
Subharti Medical College and Hospital
Meerut, Uttar Pradesh, 250005
Dr.Selvan's homeopathy
Mumbai, Maharashtra, 400017
Omkar ENT Hopital
Nashik, Maharashtra, 422002
Moraya Multispeciality Hospital,
Pune, Maharashtra, 411033
Silver brich multispeciality hospital
Pune, Maharashtra, 411041
Dr.D Y Patil medical college hospital & Research Center
Thane, Maharashtra, 400706
About this study
Official title: 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.
- Conditions
- Cognitive Health
- Being tested
- Arm 1: TisinaTM complex, Arm 2: Placebo (Microcrystalline Cellulose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: TisinaTM complexDietary supplement
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)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: TisinaTM complex | Active comparator | 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. Receives: Dietary Supplement: Arm 1: TisinaTM complex |
| Arm 2: Placebo (Microcrystalline Cellulose) | Placebo comparator | 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. Receives: Dietary Supplement: Arm 2: Placebo (Microcrystalline Cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the effect of Tisina complex on improvement in Cognition status (attention, memory, fluency, language, Visuospatial) as assessed by Addenbrooke's Cognitive Examination III (ACE III) as compared to baseline and placebo.
On Day 0, participants will receive study instructions. Cognitive status will be assessed on Days 20, 45, and 90 to evaluate symptom improvement and the efficacy of the investigational product (IP) compared to baseline and placebo.
Measured: Day 0, Day 20, Day 45 and Day 90]
Secondary outcomes (5)
To asses the effect of Tisina complex in comparison to baseline and placebo on Loudness, distress, and QOL in Tinnitus as assessed by Tinnitus Visual Analog Scale (TVAS).
The Visual Analog Scale (VAS) is a self-reported tool used to assess tinnitus-related symptoms, including loudness, distress, and quality of life (QoL). At the randomization visit, participants will rate their symptoms on an e-diary using provided login credentials. Symptom severity will be assessed on Days 20, 45, and 90 to evaluate improvements and the efficacy of the investigational product (IP) compared to baseline and placebo.
Measured: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on severity of tinnitus for Tinnitus loudness , Tinnitus frequency pitch, and Minimum masking level (MML) by Audiometric tests.
On Day 0, participants will receive study instructions. Tinnitus loudness, frequency pitch, and minimum masking level will be assessed on Days 20, 45, and 90 to evaluate the efficacy of the investigational product (IP) compared to baseline and placebo.
Tinnitus loudness and frequency pitch areacoustic parameters measured in decibels (dB) above hearing threshold at the indicated frequency, mixing-point, and minimum masking level. In most cases, tinnitus pitch or frequency range is between 5 kHz and 10 kHz53, and loudness between 5 and 15 dB above the hearing threshold and The minimum masking level (MML) is defined as the minimal intensity of a masking sound required to mask tinnitus. It is a technique of measuring the intrusiveness of tinnitus and the acceptance of masking.
Measured: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on Change in Subjective discomfort due to Tinnitus as assessed by Tinnitus Handicap inventory (THI).
The Tinnitus Handicap Inventory (THI) is a self-reported questionnaire completed by participants at baseline using an e-diary with provided login credentials. Difficulties related to tinnitus will be assessed on Days 20, 45, and 90 to analyze improvements in subjective discomfort and evaluate the efficacy of the investigational product (IP) compared to baseline and placebo.
Measured: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on stress as assessed by the Perceived Stress Scale (PSS).
On the randomization day, participants will self-administer a questionnaire on an e-diary, assessing stress and cognitive difficulties related to tinnitus. Stress levels will be evaluated on Days 20, 45, and 90 to analyze improvements compared to baseline and assess the efficacy of the investigational product (IP) versus placebo.
Measured: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on Quality of life as assessed by "Quality of Life in Neurological Disorders" questionnaire for Sleep and cognition function.
On the randomization day, participants will self-administer a questionnaire on an e-diary to assess the quality of life related to cognitive difficulties associated with tinnitus. Quality of life will be evaluated on Days 20, 45, and 90 to analyze improvements compared to baseline and assess the efficacy of the investigational product (IP) versus placebo.
Measured: Day 0, Day 20, Day 45 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-blind, Placebo-controlled, Parallel study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859346
- Sponsor's protocol ID
- BCH/240702/IP/MCI
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06859346
- Acronym / sponsor ID
- BCH/240702/IP/MCI
- Conditions
- Cognitive Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Randomized, Double-blind, Placebo-controlled, Parallel study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: TisinaTM complex | Active comparator | Dietary Supplement: Arm 1: TisinaTM complexRoute 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) | Placebo comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: TisinaTM complexRoute 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. | Dietary supplement | Arm 1: TisinaTM complex |
| 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. | Dietary supplement | Arm 2: Placebo (Microcrystalline Cellulose) |
Primary outcome
To asses the effect of Tisina complex on improvement in Cognition status (attention, memory, fluency, language, Visuospatial) as assessed by Addenbrooke's Cognitive Examination III (ACE III) as compared to baseline and placebo.
Time frame: Day 0, Day 20, Day 45 and Day 90]
On Day 0, participants will receive study instructions. Cognitive status will be assessed on Days 20, 45, and 90 to evaluate symptom improvement and the efficacy of the investigational product (IP) compared to baseline and placebo.
5 secondary outcomes
To asses the effect of Tisina complex in comparison to baseline and placebo on Loudness, distress, and QOL in Tinnitus as assessed by Tinnitus Visual Analog Scale (TVAS).
Time frame: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on severity of tinnitus for Tinnitus loudness , Tinnitus frequency pitch, and Minimum masking level (MML) by Audiometric tests.
Time frame: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on Change in Subjective discomfort due to Tinnitus as assessed by Tinnitus Handicap inventory (THI).
Time frame: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on stress as assessed by the Perceived Stress Scale (PSS).
Time frame: Day 0, Day 20, Day 45 and Day 90
To asses the effect of Tisina complex in comparison to baseline and placebo on Quality of life as assessed by "Quality of Life in Neurological Disorders" questionnaire for Sleep and cognition function.
Time frame: Day 0, Day 20, Day 45 and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: TisinaTM complex in people with Cognitive Health, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the effect of Tisina complex on improvement in Cognition status (attention, memory, fluency, language, Visuospatial) as assessed by Addenbrooke's Cognitive Examination III (ACE III) as compared to baseline and placebo. (time frame: Day 0, Day 20, Day 45 and Day 90]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.