The effect of Etrifel (a product of Iranian traditional medicine) on patients with migraine and gastrointestinal symptoms
Design
A randomized clinical trial with a control group based on community with parallel and double-blind groups.
Settings and conduct
A total of 124 patients with gastroenterological migraine referred to Shahid Sadoughi Clinic of Yazd were selected and randomly divided into two equal groups according to entry and exit criteria. Both groups received daily 200mg of sodium valproate and 50mg of placebo in the control group and 50mg of infusion in the intervention group. Patients evaluated clinically before and eight weeks after treatment. The patient and the analyst were not aware of the therapeutic content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female patients aged 18-65. Migraine with gastrointestinal symptoms. Patients are aware of the diagnosis of their illness, are Iranian and know the Persian language and available. Number of headache attacks at least 4 times a month with a duration of more than 30 minutes and severity of 4 or more (according to VAS). The patient's written consent form will be completed
Exclusion criteria: The patient is diagnosed during or before pregnancy. Drug and alcohol abuse, or other traditional medicine, such as needles or herbal medicines
Intervention groups
The intervention group daily received 50 mg of Attrafil Minor and 200 mg of sodium valproate and the control group received daily 50 mg of placebo and 200 mg of sodium valproate.
Main outcome variables
The effect of Etrifel (a product of Iranian traditional medicine) on patients with migraine and gastrointestinal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039331N1
Registration date:2018-08-24, 1397/06/02
Registration timing:retrospective
Last update:2018-08-24, 1397/06/02
Update count:0
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
hemaseh tavahen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
h.tavahen@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
empty
Scientific title
The effect of Etrifel (a product of Iranian traditional medicine) on patients with migraine and gastrointestinal symptoms
Public title
The effect of Etrifel (a product of Iranian traditional medicine) on patients with migraine and gastrointestinal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine sufferers with gastrointestinal symptoms (peptic ulcer) based on the diagnostic CRIs contained in authentic traditional medicine texts. Their headache has been confirmed by a clinical examination and diagnosis of a physician according to the IHS diagnostic criteria.
Patients are aware of their diagnosis.
Persian and know the Persian language and are available.
Number of headache attacks at least 4 times a month with a duration of more than 30 minutes and severity of 4 or more (according to VAS).
Patient's written consent.
Exclusion criteria:
Patient dissatisfaction with the continuation of the study.
The patient is diagnosed during or before the pregnancy.
Drug and alcohol abuse, or other traditional medicine, such as needles or herbal medicines
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
140
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two intervention and control groups. To randomize the number of participants, the envelopes with the letters A and B were used. Each participant selected an envelope. Group A was considered intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the patients were divided randomly into two groups of intervention and control, treatment was started. The patient and person who analyzed Data was unaware of the therapeutic content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Faculty of Traditional Medicine. Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8951737915
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.SSU.REC.1395.194
Health conditions studied
1
Description of health condition studied
بیماران میگرنی دارای سردرد مشارکتی معدی
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Determine the rate of recovery from atrophil in migraine patients with gastroenterological symptoms
Timepoint
Before the intervention and 8 weeks after the intervention, the physician's global assessment was evaluated. Also, 4 weeks after the start of the intervention, a questionnaire was used to answer the treatment and possible complications.
Method of measurement
Notes and daily reports of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily treatment with sodium valproate 200 mg per day and Attrafilet Minor 50 mg before lunch and dinner
Category
Treatment - Drugs
2
Description
Control group: Daily treatment with sodium valproate 200 mg daily and placebo tablets 50 mg before lunch and dinner
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic of Shahid Sadoughi Hospital in Yazd
Faculty of Traditional Medicine., Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
90
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
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Ardakan Traditional Medicine., Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Ardakan Traditional Medicine, Imam Khomeini street
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Ardakan Traditional Medicine, Imam Khomeini street.
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be available to applicants upon identification and the patients will be provided at the discretion of the research and student deputy of the Ardakan Faculty of Medicine and three years after the publication of the article.
When the data will become available and for how long
Three years after the publication and publication of the article
To whom data/document is available
Specialists and researchers of traditional medicine and doctors
Under which criteria data/document could be used
After unidentifiable patients and patients at the discretion of the Research and Student Vice-Dean of the Faculty of Ardakan Traditional Medicine and three years after the publication of the paper for researchers and medical and health professionals
From where data/document is obtainable
E-mail the responsible person and, with the permission of the vice president of research and student of Yazd University of Medical Sciences
What processes are involved for a request to access data/document
Inform the person in charge and coordinate with the deputy research and student of Yazd University of Medical Sciences