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A Study to evaluate the efficacy and safety of investigational product in cognitive disorder in healthy volunteers

A Randomized, Double Blinded, Placebo Controlled Clinical Study to evaluate the efficacy and safety of investigational product COGNIQUE in improving the normal cognitive function in healthy volunteers. - COGNIQUE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016943
Enrollment
30
Registered
2019-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Study drug: Capsule to be taken once daily for 21days Control Intervention1: Placebo: Capsule to be taken once daily for 21days

Sponsors

Aurea Biolabs P Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Subjects aged between 18 to 40 years and in good health. b. Subjects not taking any drugs or medications (excluding the contraceptives) c. Nonsmokers d. Subjects must refrain from caffeine or alcohol for at least 12 hours prior to testing.

Exclusion criteria

Exclusion criteria: 1. Subjects using nutritional supplements for cognitive function 2 weeks prior to enrolling in study 2. Subjects affected by Attention Deficit or other related disorders, psychiatric or neurological diseases (including aphasia, sensory, motor or visual disturbances which could affect test results) and subjects diagnosed with anxiety or depression. 3. Subjects with mental disabilities 4. Subjects with head injuries. 5. Subjects with medical conditions such as diabetes, hypoglycemia, psychiatric disorders, epilepsy, gastrointestinal disorders, cancer, coagulation disorders, cardiovascular, lung, kidney, thyroid, liver diseases, excessive consumption of alcohol or substance abuse/dependence. 6. Subjects taking Coumadin, tricyclic, antidepressants, antipsychotics, and anticonvulsants or subjects already taking medications for cognitive functioning. 7. Subjects who are pregnant or lactating or who plan to become pregnant.

Design outcomes

Primary

MeasureTime frame
â?¢ Compare Cognitive Battery Test - Cambridge Neuropsychological Test Automated Battery (CANTAB) from to end of study â?¢ Monitoring of Adverse Event. Timepoint: day1 day21

Secondary

MeasureTime frame
Compare Cognitive Battery Test - Cambridge Neuropsychological TestTimepoint: day1 day21

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt Ltd

pm@bioagiletherapeutics.com08043754520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026