None listed
Conditions
Interventions
Intervention1: Tab. Cetirizine: 10 mg single dose
Intervention2: Tab. Levocetirizine: 5 mg Single Dose
Control Intervention1: Tab. Promethazine: 25 mg single dose
Control Intervention2: Placebo: One t
Sponsors
Dr. B. Gitanjali
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18-40 years of age 2. Either sex
Exclusion criteria
Exclusion criteria: 1. Subjects on concomitant medications 2. Chronic smokers and alcoholics 3. Subjects with known sleeping disturbances and altered circadian rhythm 4. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Psychometrics using a computerized psychomotor testing instrument, consisting of a battery of tests. The tests are as follows:  Finger tapping test  Simple reaction time  Choice reaction time  Choice discrimination test  Digit picture substitution test  Digit symbol substitution test  Digit letter substitution test  Card sorting test  Digit vigilance test  Numeric working memory test  Immediate picture recall test 2. Sedation using Line Analogue Rating Scales for sedation (LARS) (LARS is employed as a measure of the subjective effects of psychoactive drugs) Timepoint: Pretreatment baseline measurements of the above parameters will be done. Following administration of the drug, subjects will be required to perform a series of tests of cognitive function and psychomotor performance at 1, 3, 6 and 12 hours post dose. A washout period of 7 days will be given between the administrations of drugs. Subjective evaluation of sedation will be done using LARS. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr. Shahid Akhtar
MD Postgraduate, Department of Pharmacology, JIPMER, Pondicherry
Outcome results
None listed