Effect of single dose Bilastine, desloratadine, chlorpheniramine and placebo on psychomotor functions in healthy human volunteers: A double blind placebo controlled cross over design clinical Trial

Justification of the study:

Newer antihistamines differ from classic antihistamines by not blocking cholinergic or central H1 receptors, resulting in fewer adverse effects such sedation and reduced psychomotor performance [15]. Some investigations have shown that second-generation H1 antihistamines can also cause decreased psychomotor function and drowsiness [1,16,17]. Theoretical explanation is there for non-sedative property of bilastine but there no as such studies using bilastine for its psychomotor performance had been carried out. This drug is being nowadays used for treatment of allergies and rhinitis, etc, hence, this study is planned to compare the effect of newer H1 antihistaminics like bilastine, desloratadine with the older seadtiveH1 antihistaminics chlorphenamine and placebo in healthy human volunteers.

3.0 Research Question

What is the effect of single dose bilastine, desloratadine, chlorpheniramine and placebo on psychomotor functions in healthy human volunteers?Top of Form

Hypothesis

H1- There is no difference between the effect of single dose bilastine, desloratadine, chlorpheniramine and placebo on psychomotor functions in healthy human volunteers

H0- There is difference between the effect of single dose bilastine, desloratadine, chlorpheniramine and placebo on psychomotor functions in healthy human volunteers

4.0 AIM

 To find out the difference between the effect of single dose bilastine, desloratadine, chlorpheniramine and placebo on psychomotor functions in healthy human volunteers

5.0 Objectives

5.1 Primary Objective

To determine the percentage of healthy human volunteers having different effect on psychomotor functions with single dose Bilastine, desloratadine, chlorpheniramine and placebo.

6.0 Plan of WorK

**Healthy human
volunteers of either sex will be recruited for the study**

|

Healthy volunteers meeting exclusion

criteria will be excluded

| |Patients meeting inclusion criteria will be recruited and randomized to different 4 groups after one wash out period randomized for next drug with Latin square design

| |Psychomotor test with paper pencil and Instruments which will be performed before and after drug administration at 2 hrs and 4 hrs

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|Data recorded in Case Record Form and Data will be analysed

| |Publication of report

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7.0 Methodology

7.1 Study Design

Randomized double blind placebo controlled single dose cross over design clinical trial

7.2 Study site

The study will be conducted in the Department of Pharmacology, All India Institute of Medical Sciences, Raipur (Chhattisgarh). The data will be analysed in the Department of Pharmacology, AIIMS Raipur.

7.3 Study Duration

The study will be conducted prospectively for the duration of 6 months

7.7 Study variables

Independent variable: Age, Sex, Drugs like bilastine, desloratadine, chlorphenamine maleate and placebo

Dependent variable: Observations of DLST (Digit letter substitution test), SLCT (six letter cancellation test, Zig-zag tracking test (Maze test), Hand steadiness tester (hole type) and  multiple choice reaction time apparatus.

7.8  Study procedure

7.8.1 Drugs used in the study

All the four drugs that will be used for carrying out this study will be coded as:

Drug A: Tab Bilastine 20 mg

Drug B: Tab Chlorpheniramine maleate 4 mg

Drug C: Tab Desloratadine 5 mg

Drug D: Placebo (Vitamin C 50 mg)

RANDOMIZATION PROCESS:

The Lattice square design will be used for randomization of the study participants to get 16 radnom codes for 16 study participants at a time.

A

B

C

D

|D

A

B

C

|C

D

A

B

|B

C

D

A

ALLOCATION CONCEALMENT:

Random sequence will be generated for 16 study participants with the help of lattice square design and will be kept in sealed opaque envelop with person who is not directly related with the study and the codes will be opened on the day of study. This will be done for 4 times so that each participant will be exposed to each of the drug.

BLINDING:

Drugs A, B, C and D will be put in the empty capsules to make the drug preparation identical in colour. Drug will be put in the containers and will be labelled as A, B, C and D and will be kept with person who will be carrying out randomization and drugs will be issued by this person to PI/Co-PI for carrying out the study.

DRUG ADMINISTRATION AND GENERAL INSTRUCTIONS:

Drug A/B/C/D will be given with the glass of water to the study participants Baseline reading will be taken before drug administration and 2 and 4 hrs after the drug administration. Study participants can take their routine snacks and meals. Volunteers should take adequate sleep night before the study day and light breakfast in the morning on day of experiments (preferably 2 hr before). Volunteers should not consume extra tea / coffee or stimulants /depressant drugs other than the routine tea/ coffee. Caffeinated drink or smoking should be avoided at least 2 hours before the experiment. Volunteers should get complete instruction of the procedure and its rehearsal, to avoid any conditional anxiety of volunteers. Avoid driving / handling heavy machineries after the experiment.