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CTRI Number  CTRI/2021/11/038228 [Registered on: 24/11/2021] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Antihistamines in migraine Prophylaxis  
Scientific Title of Study   “COMPARISON OF EFFICACY AND TOLERABILITY OF LEVOCETIRIZINE WITH MONTELUKAST-LEVOCETIRIZINE COMBINATION AS AN ADD-ON THERAPY IN MIGRAINE PROPHYLAXIS”,-An open label, Prospective, Comparative Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Najma Sherin M  
Designation  Post graduate  
Affiliation  Institute of Pharmacology, Madras Medical College  
Address  Institute of Pharmacology Madras medical college Chennai 3
No.3, Kandappa lane Periamet Chennai 3
Chennai
TAMIL NADU
600003
India 
Phone  8072010142  
Fax    
Email  najmasherin09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chenthamarai  
Designation  Associate Professor  
Affiliation  Institute of Pharmacology, Madras Medical College  
Address  Institute of Pharmacology Madras medical college Chennai 3

Chennai
TAMIL NADU
600003
India 
Phone  9445656912  
Fax    
Email  gchenthamarai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chenthamarai  
Designation  Associate Professor  
Affiliation  Institute of Pharmacology, Madras Medical College  
Address  Institute of Pharmacology Madras medical college Chennai 3

Chennai
TAMIL NADU
600003
India 
Phone  9445656912  
Fax    
Email  gchenthamarai@gmail.com  
 
Source of Monetary or Material Support  
Madras medical college  
 
Primary Sponsor  
Name  Madras medical college  
Address  Institute of Pharmacology Madras medical college Chennai-3  
Type of Sponsor  Research institution and hospital 
 
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 Najma Sherin   Rajiv Gandhi Government General Hospital   Institute of Neurology Chennai 3
Chennai
TAMIL NADU 		 8072010142

najmasherin09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G431||Migraine with aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Propranolol, Amitryptyline, Sodium valproate   T.Propranolol 40mg/T. Amitriptyline 25mg/T. Sodium Valproate 200mg They can be given either as single or in combination therapy depending upon the treatment protocol followed by physician. 
Intervention  Propranolol, Amitryptyline, Sodium Valproate, Levocetirizine   T.Propranolol 40mg/T. Amitriptyline 25mg/T. Sodium Valproate 200mg They can be given either as single or in combination therapy depending upon the treatment protocol followed by physician. Add-on therapy with Levocetirizine  
Intervention  Propranolol, Amitryptyline, Sodium Valproate, Montelukast-Levocetirizine  T.Propranolol 40mg/T. Amitriptyline 25mg/T. Sodium Valproate 200mg They can be given either as single or in combination therapy depending upon the treatment protocol followed by physician. Add-on therapy- Montelukast- Levocetirizine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with Migraine headache as per ICHD-3 criteria
Patients fulfilling the criteria for the prophylaxis of Migraine
Age group of 18-60 years of age
Sex- Both male and female
Patients who are willing to participate in this study 
 
ExclusionCriteria 
Details  Patients with headache other than migraine
Patients with complicated migraine like ophthalmic, hemiplegic or migraine with brainstem aura
Patients with H/O severe drug allergy
Patients with H/O severe co-morbidities like hypertension, Coronary artery disease, uncontrolled Diabetes Mellitus, thyroid disease, renal or liver disease, asthma.
H/O any drug abuse or drug dependence
Patients with H/O any psychiatric illness
Pregnant ladies, lactating mothers and children less than 18 years of age 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
End points of the study 1. Proportion of patients with 50% reduction in frequency of attacks at the end of 3rd month of the study
 		 At 3rd month of study
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the reduction in frequency and severity of pain intensity at the end of 6th month of the study
To observe for any adverse effect with study drug 		 At 6 months of study 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/11/2021 
Date of Study Completion (India) 28/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/02/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Histamine has been known to play an important role in the pathogenesis of 
vascular headache and the role of antihistamines in the role of Migraine 
prophylaxis need to be studied (1).  
Few studies suggest that there is an  increased levels of Histamine in Migraine patients during the head ache attack and the symptom free period(2).
The relationship between allergy and migraine can be based, in part, on an IgE-mediated mechanism, and histamine release plays an important role. Thus avoidance of allergic conditions in migraine patients may be a simple, helpful way for prophylaxis of migraine.
 
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