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CTRI Number  CTRI/2025/02/081350 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate how Tisina™ complex affects brain health in people with mild memory and thinking difficulties. 
Scientific Title of Study   A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study to assess the effect of TisinaTM complex on Cognitive Health in individuals with Mild Cognitive Impairment  
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BCH/240702/IP/MCI VERSION: 2 DATE: 28th March 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd, room no. 118, B Morya House, off New Link Road Andheri West Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Pooja Gorule 
Designation  Project Lead– Clinical Operation 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd, room no 118, B Morya House, off New Link Road Andheri West Mumbai.

Mumbai
MAHARASHTRA
400053
India 
Phone  8655728947  
Fax    
Email  pooja.g@vediclifesciences  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –400053, Maharashtra, India 
 
Primary Sponsor  
Name  Bridges Consumer Healthcare 
Address  811 Broad St Suite 600, Chattanooga, TN 37402, United States 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrUmesh Joshi  Aster Adhar Hospital  Near, R. S. No. 628, B Ward, near KMT Workshop, Shastri Nagar, Kolhapur, Maharashtra-416012, India.
Kolhapur
MAHARASHTRA 		 9225068503

drumeshjoshi.kcro@gmail.com 
Dr Yogesh Dabholkar  Dr.D Y Patil medical college hospital & Research Center  sector 5 Nerul Thane-400706 Maharashtra, India.
Thane
MAHARASHTRA 		 9967902777

yogesh.dabholkar@dypatil.edu 
DrVishwakarma  Dr.Selvans homeopathy   27 42 7A 1st wadi kumbharwada near D mart Dharavi Mumbai-400017, Maharashtra, India.
Mumbai
MAHARASHTRA 		 9833740611

mshankarv@gmail.com 
Dr Navneeta Gangwar  Jaipur National University  Jaipur-Agra Bypass, near New RTO office, Jagatpura, Jaipur, Rajasthan 302017
Jaipur
RAJASTHAN 		 9257036514

Research2jnu@gmail.com 
DrAvinash Wachasundar  Moraya Multispeciality Hospital  Ashwin medical foundation moraya multispeciality hospital Power House Chowk, Opp. PMT Bus Stop,Chinchwad Gaon,Pimpri- Chinchwad, Maharashtra-411033, India
Pune
MAHARASHTRA 		 9822046072

avinashwacha@gmail.com 
DrMukesh More  Omkar ENT Hopital  Hopital SK empire near ved mandir mico circle trambkeshwar road, Nashik, Maharashtra-422002, India
Nashik
MAHARASHTRA 		 9224507915

drmmore3@gmail.com 
DrPravin Misal  Silver brich multispeciality hospital  20/10/11, U.P.D.Construction,S.No.6, Plot No.1 To Plot No.4, Dhayari Road, near Sawatamali Mandir, Narhe, Pune, Maharashtra-411041, India.
Pune
MAHARASHTRA 		 9082425484

misal899.suvarna@gmail.com 
Dr Chandresh Agarwal  Subharti Medical College and Hospital  Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Uttar Pradesh 250005
Meerut
UTTAR PRADESH 		 9873200745

Chandresh02@gmail.com 
Dr Monika Bhagat  Vishwaraj Hospital  , Near Loni Railway station Loni Kalbhor, Solapur - Pune Hwy, Pune, Maharashtra-412201, India.
Pune
MAHARASHTRA 		 9730759029

monikabbhagat@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Central Independent Ethics Committee-CIEC  Approved 
Ethicare Ethics committee  Approved 
IEC for Biomedical & health research  Approved 
IEC of MAEERs Vishwaraj hospital  Not Applicable 
Instituitional Ethics Committee,JNU Institute for Medical Sciences and Research center  Approved 
Moraya institutional ethics committee,  Not Applicable 
Muktai institutional ethics committee,  Not Applicable 
Subharti Medical College and Hospital Institutional Ethics Committee   Approved 
Sunrise ethics committee  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H931||Tinnitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   2 caplets three times a day (Total 6 caplets per day) with meal  
Intervention  TisinaTM complex  2 caplets three times a day (Total 6 caplets per day) with meal  
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.more than or equal to 4 cups daily (more than 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. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess 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.  Day 0, Day 20, Day 45 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Tisina™ complex in comparison to baseline and placebo on loudness, distress, and Quality of life (QoL) in Tinnitus as assessed by Tinnitus Visual Analog Scale (T-VAS)  Day 0, Day 20, Day 45 and Day 90 
To assess 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.   Day 0, Day 20, Day 45 and Day 90 
To assess 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).   Day 0, Day 20, Day 45 and Day 90 
To assess the effect of Tisina™ complex in comparison to baseline and placebo on stress as assessed by the Perceived Stress Scale (PSS).   Day 0, Day 20, Day 45 and Day 90 
To assess the effect of Tisina™ complex in comparison to baseline and placebo on quality of life as assessed by Neuro-QOL questionnaire for Sleep and cognition function.   Day 0, Day 20, Day 45 and Day 90 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) 10/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The present study is a Randomized, Double-blind, Placebo-controlled, Parallel Clinical study. Up to around 112 individuals will be screened and considering a screening failure rate of 25%, approximately 84 will be randomized in a ratio of 1:1 to receive either TisinaTM complex or matching placebo. . Each group will have at least 32 completed participants (total 64 completers) after accounting for a 25% withdrawal/ dropouts rate. The intervention duration for all the study participants is 90 days (intervention phase).

 
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