Protocol summary

Study aim
Determining the effect of dyspepsia and reflux treatment on the number and severity of migraine headaches: a clinical trial study
Design
clinical trial with an intervention group, with a parallel group; Double blind, randomized
Settings and conduct
This study is conducted in Razi Birjand Hospital, South Khorasan Province. 60 patients with migraine are randomly divided into two intervention or control groups. At the beginning and end of the study,
Participants/Inclusion and exclusion criteria
Our study population is patients with migraine headaches (with the criteria of migraine with the indication of prophylactic treatment as described below) who referred to the neurology clinic of Razi Hospital in 1402, who also have dyspepsia, peptic ulcer, and gastroesophageal reflux disease. . Inclusion criteria include: having informed consent, age 18 to 60 years, and exclusion criteria include: history of drug use, psychotic disorder, contraindications to drug prescription, under treatment for constipation, under treatment for peptic ulcer, and drug sensitivity to drugs related to treatment. It was digestive disorders.
Intervention groups
The intervention groups are as follows: Group 1: recipients of routine migraine medications (suitable to each person's condition) and group 2: recipients of routine migraine medications + medications to resolve patients' digestive problems, such as peptic ulcer medications, PPI (pantoprazole 40 per day) Fasting in the morning), anti-reflux and necessary recommendations to prevent reflux will be included.
Main outcome variables
The duration of headache, intensity of headache and number of headaches before the intervention and 2, 4 and 6 months after the intervention are evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N28
Registration date: 2024-08-24, 1403/06/03
Registration timing: prospective

Last update: 2024-08-24, 1403/06/03
Update count: 0
Registration date
2024-08-24, 1403/06/03
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-31, 1403/06/10
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dyspepsia and reflux treatment on the number and severity of migraine headache attacks: a clinical trial study
Public title
The effect of dyspepsia and reflux treatment on the number and severity of migraine headache attacks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study Age 18 to 60 years
Exclusion criteria:
History of drug use Psychotic disorder Contraindications for drug administration Under treatment for constipation Under the treatment of peptic ulcer Drug sensitivity to drugs related to the treatment of digestive disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Placement of people in each group by a simple random block method in one of two groups 1: recipients of routine migraine medications (suitable to the conditions of each person) and group 2: recipients of routine migraine medications + medications to resolve patients' digestive problems such as Related to peptic ulcer, PPI (pantoprazole 40 every morning fasting), anti-reflux and necessary recommendations to prevent reflux will be included. For randomization, blocks of four were created as RDRD, DRDR, RDDR, DRRD, DDRR, RRDD and kept in a sealed envelope. Then one of the envelopes will be randomly removed from the first patient who came and the placement of the first 4 patients will be determined. Then randomization is done for other patients in this way.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor: The study leader (neurology assistant) asks the patients about the frequency, intensity and duration of headache before and after the intervention and records it in a checklist. In order to check the severity of the headache, the patients are asked to rate their headache from 0 to 10. Data analyst: the data is coded and according to groups 1 and 2 in the Excel file, it is provided to the data analyst, and after analyzing the results, it is collected from him by the neurology assistant in the form of groups 1 and 2.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.BUMS.REC.1402.482

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
Number of headaches
Timepoint
It is evaluated by a neurology assistant before admission, 2, 4 and 6 months after the intervention and medication.
Method of measurement
The neurology assistant asks the patient the number of headaches and records it in the checklist associated with each patient.

2

Description
Duration of headache
Timepoint
It is evaluated by a neurology assistant before admission, 2, 4 and 6 months after the intervention and medication.
Method of measurement
The neurology assistant asks the patient the duration of the headache and records it in the checklist related to each patient.

3

Description
Severity of headache
Timepoint
It is evaluated by a neurology assistant before admission, 2, 4 and 6 months after the intervention and medication.
Method of measurement
The neurology assistant first teaches about the visual and auditory measurement criteria (where 0 is no headache and 10 is the most headache), and then they are asked about the severity of the headache and it is recorded in the checklist related to each patient.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group 1: receiving routine migraine medications including propranolol 20 (manufactured by Hakim Pharmaceutical Company - Iran) every 12 hours and nortriptyline 25 daily (manufactured by Obidi Company - Iran) for 3 months.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group 2: recipients of routine migraine medications including propranolol 20 (manufactured by Hakim Pharmaceutical Company - Iran) every 12 hours and nortriptyline 25 daily (manufactured by Obidi Company - Iran) + drugs to relieve patients' digestive problems such as drugs related to peptic ulcer PPI such as pantoprazole 40 every morning on an empty stomach (manufactured by Obedi Company - Iran), anti-reflux and necessary recommendations to prevent reflux for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Nayer Bodaghi
Street address
Razi Hospital,Ghaffari Blvd, Iran- South Khorasan- Birjand.
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 939 713 0576
Email
oabstudent@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Masoud Yosefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Nayer Bodaghi
Position
Asistant Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3238 1500
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Shabnam Vafadar
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Birjand, Birjand University of Medical Sciences, Ghafari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3236 6000
Email
vafadar.shabnam@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3238 1212
Email
zabihullahmohaghegh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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