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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
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.
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.
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
Thane, Maharashtra, India
Jaipur National University
Jaipur, Rajasthan, India
Subharti Medical College and Hospital
Meerut, Uttar Pradesh, India
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.
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 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.
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.
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.
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).
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.
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).
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.
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.
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.
Time frame: Day 0, Day 20, Day 45 and Day 90
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