Investigating migraine from the perspective of Persian traditional medicine and the effectiveness of Persian herbal formulation on migraine associated with functional dyspepsia
Comparison of the effect of Persian traditional medicine product with Sodium Valproate on migraine headache with functional dyspepsia
Design
randomized double-blind clinical trial (phase 2)
including 3 groups of 25 participants
Settings and conduct
75 patients were randomly divided into three groups of 25 participants and each group received double blind treatment by supervision of specialist according to the protocol
Participants/Inclusion and exclusion criteria
People with migraine headaches according to the International Classification of Headache Disorders 3rd edition (ICHD-III) with the approval of a neurologist
2) Patients with Functional Dyspepsia Based on Parkman Criteria and Parkman Functional dyspepsia Criteria
3) Patients aged 18 to 55 years
Exclusion criteria
1) Patients with chronic and acute headaches with a diagnosis other than migraine
2) Patients with uncontrolled hypertension (160 systolic and 100 diastolic systolic blood pressure).
3) Patients with cancer
4) Pregnancy and lactation
5) Peptic Ulcer
6) The occurrence or diagnosis of any systemic physical or psychologic disease including liver, kidney, heart disease and any neurologic component of the migraine during the study
7) Use drugs that cause headaches themselves, such as nitroxanthine
HIT-6 questionnaire score
Parkman criteria score
severity of headaches
duration of headache
Frequency of headache
General information
Reason for update
Acronym
no
IRCT registration information
IRCT registration number:IRCT20170317033107N3
Registration date:2020-01-11, 1398/10/21
Registration timing:retrospective
Last update:2020-01-11, 1398/10/21
Update count:0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
ali gholampour
Name of organization / entity
Mashhad medical science- iranian traditional college
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8930
Email address
gholampoura1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
University research departments
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-07-06, 1396/04/15
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2019-05-22, 1398/03/01
Scientific title
Investigating migraine from the perspective of Persian traditional medicine and the effectiveness of Persian herbal formulation on migraine associated with functional dyspepsia
Public title
Effectiveness of Persian herbal formulation on migraine associated with functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine headache concurrently with functional dyspepsia
Migraine headache criteria based on the latest version and presentation of dyspepsia
Exclusion criteria:
Headache with non diagnosis of migraine
Stomach disorder with non diagnosis of functional dyspepsia
Age
From 17 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individualized randomization with statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blind clinical trial in which patients and researchers were not informed of the treatment group and when entered into the Persian traditional pharmacy of Imam Reza Hospital and apothecary after viewing the number and referring to the numbers table and determining treatment group the medication was given 3 months each 15 days separately.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Organization of Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
ir.mums.ac.rec.1395.585
Health conditions studied
1
Description of health condition studied
migraine associated with functional dyspepsia
ICD-10 code
G43, G43.1
ICD-10 code description
Migraine without aura [common migraine], Migraine with aura [classical migraine] Migraine: aura without headache basilar equivalents familial hemiplegic with: acute-onset aura prolonge
Primary outcomes
1
Description
Headache frequency
Timepoint
Baseline and after 4, 8 and12 weeks of intervention
Method of measurement
Number of episodes in month
2
Description
Headache duration
Timepoint
Baseline and after 4, 8 and12 weeks of intervention
Method of measurement
Duration of each episode (in hour)
3
Description
Headache severity
Timepoint
Baseline and after 4, 8 and12 weeks of intervention
Method of measurement
Visual Analog Scale
4
Description
Severity of functional dyspepsia
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Parkman's criteria
Secondary outcomes
1
Description
Effect of headache on quality of life
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
HIT-6 questionaire
Intervention groups
1
Description
Intervention group 1": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin (Sanofi pharmaceutical company) two tablets of 200 mg each day and amitriptyline ( Iran daroo pharmaceutical company) 1 tablet 10 mg once a day all of them for three months.
Category
Treatment - Drugs
2
Description
"Intervention group 2": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin placebo tablet twice a day.
Category
Treatment - Drugs
3
Description
"Control group": Three placebo capsules of 750 mg as like as Traditional Medicine Product capsules three times a day plus Depakin tablets 200 mg twice a day and amitriptyline tablet 10 mg once a day.
Central organization of Mashhad university of medical sciences, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
-
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Gholampour
Position
PhD student of Iranian tradditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
Email
Gholampoura1@mums.ac.ir
Web page address
http://tim.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Anushirvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
East door of Ferdowsi University, School of Persian and complementary medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
Email
dr.Anushiravani@gmail.com
Web page address
http://tim.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Gholampour
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
East door of Ferdowsi University, School of Persian and complementary medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0098518848930
Fax
Email
Gholampoura1@mums.ac.ir
Web page address
http://tim.mums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The spss file contains the following information from the participants:
demographic information
HIT-6 questionnaire and parkman criteria scores
When the data will become available and for how long
6 month after publication of results
To whom data/document is available
The data is only accessible to researchers working in academic centers
Under which criteria data/document could be used
New research on the data of this study is allowed with the written permission of the corresponding author
From where data/document is obtainable
Contact corresponding author of the published article, Dr. Majid Anushiravani via following email address:
dr.anushiravani@gmail.com
What processes are involved for a request to access data/document
1. send a request to corrsponding author via an academic email address
2. Check the request by corresponding author
3. If applicable, send the data file by email