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RECRUITING
NCT06859346
NA

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

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-04-01

Completion Date

2025-12-31

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

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.

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.

Locations (8)

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