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A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment
Sponsor: Vedic Lifesciences Pvt. Ltd.
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
Conditions
Interventions
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.
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