A Study to evaluate the efficacy and safety of investigational product in cognitive disorder in healthy volunteers
- Registration Number
- CTRI/2019/01/016943
- Lead Sponsor
- Aurea Biolabs P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Compare Cognitive Battery Test - Cambridge Neuropsychological Test Automated Battery (CANTAB) from to end of study <br/ ><br>â?¢Monitoring of Adverse Event. <br/ ><br>Timepoint: day1 day21
- Secondary Outcome Measures
Name Time Method Compare Cognitive Battery Test - Cambridge Neuropsychological TestTimepoint: day1 day21