| CTRI Number |
CTRI/2024/09/073430 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study compares Propranolol and Metoprolol for migraine prophylaxis in a hospital trial. |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy and Safety of Oral Propranolol Vs
Oral Metoprolol for Prophylaxis in Patients of Migraine in a Tertiary
Care Hospital:
A Prospective Randomized Double Blind Study |
| 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 Ramizahmad Maiyuddinbhai Mansuri |
| Designation |
Post Graduate Resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Ground floor, PG room, Gajra Raja Medical College, Veer Savarkar Marg, Lashkar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
918866774452 |
| Fax |
|
| Email |
ramizahmadmansuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Singh Kushwah |
| Designation |
Designated Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Ground floor, PG Room, Gajra Raja Medical College, Veer Savarkar Marg, Lashkar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
8889925777 |
| Fax |
|
| Email |
dev_singh433@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Singh Kushwah |
| Designation |
Designated Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Ground floor, PG Room, Gajra Raja Medical College, Veer Savarkar Marg, Lashkar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
8889925777 |
| Fax |
|
| Email |
dev_singh433@yahoo.com |
|
|
Source of Monetary or Material Support
|
| J.A GROUP OF HOSPITALS,GAJRA RAJA MEDICAL COLLEGE,VEER SAVARKAR MARG,LASHKAR,GWALIOR,MADHYA PRADESH,INDIA.PIN CODE-474001 |
|
|
Primary Sponsor
|
| Name |
Dr Ramizahmad Maiyuddinbhai Mansuri |
| Address |
J.A GROUP OF HOSPITALS,GAJRA RAJA MEDICAL COLLEGE,VEER SAVARKAR MARG,LASHKAR,GWALIOR,MADHYA PRADESH,INDIA.PIN CODE-474001 |
| 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 |
| DR RAMIZAHMAD MAIYUDDINBHAI MANSURI |
J.A GROUP OF HOSPITALS,GAJRA RAJA MEDICAL COLLEGE,VEER SAVARKAR MARG,GWALIOR |
Department of Neurology,Ground Floor,OPD room no.06
Gwalior
MADHYA PRADESH |
8866774452
ramizahmadmansuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee (IEC) GAJRA RAJA MEDICAL COLLEGE,GWALIOR,M.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metoprolol |
Oral Metoprolol 50mg once daily after breakfast for duration of 4 months |
| Intervention |
Propranolol |
Oral Propranolol 40mg once daily after breakfast for duration of 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient will be taken as per International Headache Society Criteria for Migraine with Aura.
Patient will be taken as per International Headache Society Criteria for Migraine without Aura.
Patients who will be willing to take part in the study with signed and written informed consent.
Patients aged between 18-65 years.
Patients could be of both male and female. |
|
| ExclusionCriteria |
| Details |
Pregnant , breast feeding, child bearing age using contraception.
Patients having asthma, bradycardia and COPD.
History of Bronchospasm.
Patients having Coronary Artery Diseases .
Patients less than 18years & more than 65years.
Patient having chronic in capacitating illness eg.AIDS,cancer,TB.
Patient whose primary headaches were other than migraine headaches
e.g. With a clinical history of stroke or Transient Ischemic Attack. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Propranolol versus Metoprolol as Prophylactic Agent in Migraine using The Migraine Disability Assessment Test and Headache Impact Test 6 |
Baseline 4 weeks 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Adverse drug reactions between Propranolol versus Metoprolol which will be used as prophylactic agent in Migraine by maintaining Headache Diary |
Baseline 4 weeks 8 weeks & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/09/2024 |
| 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="1"
Months="0"
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
|
The study is a prospective randomized double blind study on the patients of Migraine. The Study will be conducted on 80 patients being divided amongst 2 groups of 40 each in the Department of Neurology and the Department of Pharmacology in the J. A. Group of Hospitals Gwalior, Madhya Pradesh and G. R . Medical College, Gwalior, Madhya Pradesh, India. The groups will be allocated on the basis of numbered chits being chosen by the patients themselves. The study involves a duration of 12 months and will be focusing on the parameters of Efficacy and Safety. The patients will be guided and asked to give proper written consent before getting enrolled for the study. The test drugs under evaluation will be Tablet Propranolol 40 mg once a day after breakfast in one group which will be compared with Tablet Metoprolol 50 mg once a day after breakfast being given for a period of 3 months respectively. The various parameters under consideration will be taken care with regular follow-ups at 4, 8 and 12 weeks respectively. Any ADRs will be reported to the concerned authorities. The expected ADRs will be managed as per the normal treatment policies against the ADRs. The endpoints of the study will be evaluated after every patient completes their entire study duration and will include the use of standardized scales namely , MIDAS scale, HIT 6 score and for classification of the migraine using ICHD 3 criteria. The financial burden of the study will be undertaken by the principle investigator. The blinding of the study will be done by an anonymous expert who is not part of the study and will be revealed at the end of the study. The study has been approved by the institutional ethics committee of the institution and proper safety protocols will be followed.
|