| CTRI Number |
CTRI/2025/02/081025 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effects of amitriptyline and propranolol on heart rate variability and lipid profile in migraine |
|
Scientific Title of Study
|
Effect of Amitriptyline and Propranolol Prophylaxis on Heart Rate Variability
and Lipid Profile in Persons with Migraine: A Prospective Cohort 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 |
ROBIN REJI |
| Designation |
Junior Resident (academic) |
| Affiliation |
|
| Address |
Dr. Robin Reji,
3rd floor, medical college block 1, department of Pharmacology, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8848765762 |
| Fax |
|
| Email |
rrrobinhood55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arup Kumar Misra |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Dr. Arup Kumar Misra
3rd floor, medical college block 1, department of Pharmacology, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9501988533 |
| Fax |
|
| Email |
arup.pharma@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ROBIN REJI |
| Designation |
Junior Resident (academic) |
| Affiliation |
|
| Address |
Dr. Robin Reji,
3rd floor, medical college block 1, department of Pharmacology, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8848765762 |
| Fax |
|
| Email |
rrrobinhood55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Robin Reji |
| Address |
Dr. Robin Reji,
Room 321, 3rd floor, AIIMS PG MALE hostel, AIIMS MANGALAGIRI, Guntur. 522503 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Robin Reji |
AIIMS Mangalagiri |
OPD building, room no. 214, 2nd floor, Department of Neurology
Guntur
ANDHRA PRADESH |
8848765762
rrrobinhood55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G431||Migraine with aura, (2) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amitriptyline prophylaxis |
assessing its effect on HRV and lipid profile
Amitriptyline: 10mg- 100mg per day, orally
Frequency: OD or BD, it will be decided on case to case basis
Duration: 3 months |
| Comparator Agent |
Propranolol prophylaxis |
assessing its effect on HRV and lipid profile
Propranolol: 40mg – 160mg per day, orally
Frequency: OD or BD, decided on case to case basis
duration of treatment: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed case of Migraine, according to the International Classification of Headache
Disorders (ICHD-3) criteria
Those who have given written informed consent for the study |
|
| ExclusionCriteria |
| Details |
History of significant cardiovascular disease (e.g., myocardial infarction, arrhythmias, heart
failure)
Patients with diabetes, HTN, dyslipidemia, Kidney and liver disease who are currently on
medication
Patients currently taking statins or other lipid-lowering therapies
Patients with a history of severe psychiatric disorders
Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. changes in HRV on Amitriptyline and Propranolol prophylaxis
|
changes to be observed after 3 months of follow up after recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. change in lipid profile on Amitriptyline and Propranolol prophylaxis
2. Clinical response to migraine severity on propranolol and amitriptyline prophylaxis |
changes to be observed after 3 months of follow up after recruitment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
28/03/2025 |
| 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="2"
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
|
Migraine is a prevalent primary headache disorder marked by intense headaches and heightened sensitivity to sensory stimuli. Propranolol and amitriptyline are commonly prescribed for migraine prevention, but both medications can influence heart rate variability (HRV), impacting treatment outcomes. Research indicates that amitriptyline may reduce HRV, particularly in depressed patients, although it might enhance HRV in those experiencing neuropathic pain. In contrast, propranolol generally increases HRV, although its effects can vary among populations, such as those with hyperthyroidism. Additionally, amitriptyline is associated with unfavourable lipid profile changes, including elevated cholesterol and triglycerides. Given the established link between HRV and cardiovascular health, monitoring lipid profiles in patients treated with Propranolol and Amitriptyline is crucial to mitigate cardiovascular risks. This study aims to investigate the differential impacts of propranolol and amitriptyline on HRV and lipid profiles in migraine patients, ultimately enhancing migraine management strategies while addressing associated cardiovascular concerns. |