A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Cognitive Health

• Registration Number: NCT06859346
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-05
• Study Start: 2025-04-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-30
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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).	Day 0, Day 20, Day 45 and Day 90	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.
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.	Day 0, Day 20, Day 45 and Day 90	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.
To asses 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	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.
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.	Day 0, Day 20, Day 45 and Day 90	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.
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).	Day 0, Day 20, Day 45 and Day 90	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.

Trial Locations

Locations (8)

Jaipur National University; 🇮🇳 Jaipur, Rajasthan, India

Subharti Medical College and Hospital; 🇮🇳 Meerut, Uttar Pradesh, India

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