| 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
|
|
|
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
|
|
|
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. |