As various studies have shown that constipation severity of migraine headaches, this study intends to evaluate the effect of constipation treatment to improve migraine headaches. Therefore, patients with migraine who suffer from constipation are also divided into two groups: Lactulose syrup is given to the first group and the second group is given a placebo without the patient to know in which category. After 30 days to two months of treatment, patients are evaluated in terms of severity of migraine headache.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022226667N3
Registration date:2016-04-03, 1395/01/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Ali Jadidi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3508
Email address
jadidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-04-30, 1395/02/11
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment of constipation by lactoluse on the migraine improving in patients with migraine headache
Public title
The effect of treatment of constipation on improving migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a history of migraines for 6 months; Headache frequency by at least three times a month; Age 15 to 50 years, Avoiding the use of prophylactic medication. Exclusion criteria: unwillingness to continue the study
Age
From 15 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.ARAKMU.REC.1394.283
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache
Timepoint
Before, one and two moanth after intervention
Method of measurement
Questionnaire of visual analoge scale
Secondary outcomes
1
Description
Disability
Timepoint
Before, one and two mounth after intervention
Method of measurement
Questionnaire of MIDAS
Intervention groups
1
Description
In the intervention group, as long as patients treated constipation, in addition to the drug, given daily for 15 to 30 cc lactulose syrup.
Category
Treatment - Drugs
2
Description
The control group, in addition to medication, placebo given daily 20 cc; That is poured into the same bottles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medica lSciences
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Ashtiani
Street address
Medical School, Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
MSc of Nursing
Other areas of specialty/work
Street address
Arak, Rahahan Sq, Alamolhoda St, Arak University of Medical Sciences.
City
Arak
Postal code
Phone
+98 86 3417 3508
Fax
Email
jadidi@arakmu.ac.ir; jadidi.ali83gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Ashtiani
Position
Nourologist
Other areas of specialty/work
Street address
Arak, Rahahan Sq, Alamolhoda St, Arak University of Medical Sciences.
City
Arak
Postal code
Phone
+98 86 3222 2005
Fax
Email
r110_ashtiani@yahoo.com; jadidi.ali83@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ali Jadidi
Position
MSc of Nursing
Other areas of specialty/work
Street address
Arak, Rahahan Sq, Alamolhoda St, Arak University of Medical Sciences. Arak Markazi Iran, Islamic Republic Of
City
Postal code
Phone
+98 86 3417 3508
Fax
Email
jadidi@arakmu.ac.ir; jadidi.ali83gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)