None listed
Conditions
Interventions
Intervention1: Withania somnifera Capsules,: Dose : 250 mg Capsule
Route of Administration:Oral
Treatment Duration : 14 days
Subjects were asked to take 2 capsules BD with 240 ml of water daily for 1
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants willing to sign informed consent 2. Participants with normal healthy conditions- Normal vitals, Physical examination, Normal weight and height as per LIC chart No H/o of neuropsychological and psychiatric disorders. Participants with normal to corrected vision. Able to perform the test procedures, as per the protocol.
Exclusion criteria
Exclusion criteria: 1.H/o of psychiatric illiness, insomnia, use of any psychiatric medication. 2.H/o of drug dependence or any severe co-morbid medical conditions. 3.H/o of serious adverse reactions or hypersensitivity to any drug. 4.Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study. 5. Abnormality in routine lab investigations like complete blood picture, complete urine examination, liver function tests or renal function tests. 6.Participating in any drug trials/ research projects over the past 3 months. 7.Alcohol consumption 24 hrs before study day. 8.Tea/Coffee consumption or smoking 12 hrs before the study day. 9.Pregnant/breast feeding/ child bearing potential participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in reaction time in cognitive and psychomotor tests on treatment with withania somnifera extract compared to placeboTimepoint: Baseline (Day-1) and Post Treatment(Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of withania somnifera extract capsulesTimepoint: Baseline (Day-1) and Post Treatment(Day 15) | — |
Countries
India
Contacts
Public ContactDr P Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed