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CTRI Number  CTRI/2024/07/071575 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of single dose of antihistaminics on psychomotor functions in healthy human volunteers: A Clinical Trial 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogendra Narayanrao Keche 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Room No 2216 Department of Pharmacology Gate 5 GE Road Tatibandh AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8818882119  
Fax    
Email  drynkeche@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogendra Narayanrao Keche 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Room No 2216 Department of Pharmacology Gate 5 GE Road Tatibandh AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8818882119  
Fax    
Email  drynkeche@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogendra Narayanrao Keche 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Room No 2216 Department of Pharmacology Gate 5 GE Road Tatibandh AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8818882119  
Fax    
Email  drynkeche@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Sciences Raipur Opp Gurudwara GE Road Tatibandh Raipur Chhattisgarh India 492099  
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  All India Institute of Sciences Raipur Opp Gurudwara GE Road Tatibandh Raipur Chhattisgarh India 492099  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogendra Narayanrao Keche  All India Institute of Medical Sciences Raipur  Department of General Medicine OPD D Block, Gate No.4, AIIMS GE Road, Tatibandh, Raipur, Chhattisgarh, India 492099
Raipur
CHHATTISGARH 		 8818882119

drynkeche@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tab Bilastine 20 mg   20 mg to be given orally as a single dose with glass of water.  
Comparator Agent  Tab Chlorpheniramine maleate 4 mg   4 mg to be given orally as a single dose with glass of water. 
Comparator Agent  Tab Desloratadine 5 mg  5 mg to be given orally as a single dose with glass of water. 
Comparator Agent  Tab Vitamin C 50 mg  50 mg to be given orally as a single dose with glass of water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.The volunteers from the second MBBS students of AIIMS Raipur willing to participate in the study by giving informed written consent.
2.Age above 18 years
3.The volunteers having no abnormality in general and systemic examination as revealed by detail history and clinical examination
 
 
ExclusionCriteria 
Details  1. Hepatic disease
2. Renal disease
3. Individuals receiving cardiovascular drugs, sedatives, antianxiety drugs and other antihistamines.
4. H/o treatment with β2 agonists
5. Hyperthyroidism
6. Individuals suffering from any disease like cardiovascular disease, anxiety disorder or any other chronic illness
7. History of allergy, hypersensitivity to any medications.
8. Known case of colour blindness
9. Having impaired hearing
10. Suffering from essential tremors
11. Complaint of night blindness
12. Essential Tremors
13. K/C/O Epilepsy and H/O seizures.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the percentage of healthy human volunteers having different effect on psychomotor functions with single dose Bilastine, desloratadine, chlorpheniramine and placebo.  at baseline, 2hours and 4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   23/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

Data recorded in Case Record Form and Data will be analysed

 

Publication of report

 

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.

 
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