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CTRI Number  CTRI/2025/02/080591 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study observing medicine being prescribed to patients with migraine at SMS hospital, Jaipur  
Scientific Title of Study   A Descriptive Observational Study on Prescription Pattern among Outpatients with migraine attending the Department of Neurology at SMS Hospital, Jaipur. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tara Chand Saini 
Designation  Postgraduate Resident  
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  8003626804  
Fax    
Email  tarasaini137@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandan Verma 
Designation  Professor  
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Pharmacology, SMS Medical College, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414059213  
Fax    
Email  chandanverma1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandan Verma 
Designation  Professor  
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Pharmacology, SMS Medical College, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414059213  
Fax    
Email  chandanverma1970@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College and attached Hospitals, Jaipur , Rajasthan, India, 302004 
 
Primary Sponsor  
Name  Dr Tara Chand Saini 
Address  Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India,302004 
Type of Sponsor  Other [Self] 
 
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 
Tara Chand Saini  Department of Neurology, SMS Hospital   Room no. = 53, Out-patient Department, Department of Neurology, SMS HOSPITAL, JAIPUR, Rajasthan, India, 302004
Jaipur
RAJASTHAN 
8003626804

tarasaini137@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE, SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G43||Migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with migraine disorders visiting the out-patient department of Neurology.
2. Patients who are willing to participate or give informed consent.
3. Patients aged between 18 to 60 years of age and of either sex.
 
 
ExclusionCriteria 
Details  1. Patients with comorbidities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Average number of drugs per encounter.
Percentage of drugs prescribed with the generic name.
Percentage of encounters with antibiotics prescribed.
Percentage of encounters with injections prescribed.
Percentage of drugs prescribed from Essential Drugs List (EDL).
 
at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients with various degrees of disability as assessed by MIDAS Questionnaire.  at baseline  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   28/02/2025 
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  

Migraine is a common, chronic, and debilitating neurovascular disorder characterized by recurrent episodes of moderate to severe headache, lasting between 4 and 72 hours. These headaches are typically unilateral and pulsating, worsening with routine physical activity. Migraines are often accompanied by autonomic nervous system dysfunction, nausea, and heightened sensitivity to light and sound. According to the World Health Organization, about half of the world’s adult population experiences a headache each year. Approximately 90% of those suffering from headaches experience a reduced ability to function, and 33% need to rest in bed during headache attacks. When managing any case of headache, it is crucial to determine the specific type using the International Classification of Headache Disorders (ICHD) criteria before evaluating the response or resistance to any particular treatment. For terminating acute migraine attacks, commonly used pharmacotherapeutic options include nonsteroidal anti-inflammatory drugs (NSAIDs), 5HT1B/1D receptor agonists, and dopamine receptor antagonists. For prophylaxis, treatments often involve beta-blockers, antidepressants, anticonvulsants, and flunarizine. Additionally, new drugs approved by the FDA in 2018, such as monoclonal antibodies targeting the CGRP pathway (Erenumab, Fremanezumab, and Galcanezumab) and Ubrogepant, a calcitonin gene-related peptide receptor antagonist, have been introduced. Ubrogepant is used for the immediate treatment of migraine with or without aura.(5)

The World Health Organization (WHO) and the International Network for Rational Use of Drugs (INRUD) core prescribing indicators are essential tools for assessing the quality and rationality of prescriptions at healthcare facilities. These indicators serve as a foundation for evaluating drug use in most drug utilization studies..

This study was conducted to evaluate several aspects related to migraine patients. Firstly, it aimed to assess the prescription patterns of drugs used to treat migraines, providing insights into the pharmacotherapeutic approaches employed by healthcare providers. secondly, the   assess the awareness of migraine among patients and how this awareness correlates with various demographic factors.  Finally, the study assessed the quality of life in migraine patients, considering how migraines impact their daily activities and overall well-being.

In the present tertiary care hospital setting, no previous studies have assessed the variability in prescription patterns for migraine patients. Similarly, very few studies have evaluated the effect of medications on the quality of life in migraine patients in India. Hence, this study was planned with the objectives of assessing the drug use patterns in the outpatient department (OPD) and analyzing the effects of antimigraine medications on health-related quality of life using the MIDAS score.

 
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