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

NCT06859346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Cognitive Health

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.

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-02-10
Completion
2026-02-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859346 on ClinicalTrials.gov