This research is done to form a before - after intervention in gastric headache patients referred to the Headache Clinic of Imam Khomeini hospital in the city of Tehran, 2012. 42 patients with gastric headaches for project were selected . Patients were treated for 3 months by the traditional medicine treatment protocol and are visited once every month. In the end, the results of this proceedure, about severity, duration and frequency of headaches, will be collected in the form of data collection, and will be analysied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203089236N1
Registration date:2012-10-02, 1391/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-02, 1391/07/11
Registrant information
Name
Seyyed Mohammad Bagher Fazljou
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 1274
Email address
fazljou@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
tehran university of medical sciences
Expected recruitment start date
2012-09-23, 1391/07/02
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review of the effectiveness of traditional medicine therapy on the gastric headache
Public title
Effect of Traditional medicine treatment on headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: having gastric headaches criteria based on Iranian traditional medicine references - having at least 3 headache attacks per month - lack of specific diseases and other chronic conditions witch are interfering in the process of intervention.
exclusion criteria: wrong diagnosis - lack of cooperation volunteers - occuring complications in treatment proceedure
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Engelab St.
City
Tehran
Postal code
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
374
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G43.9
ICD-10 code description
migraine unspecified
Primary outcomes
1
Description
number of headache attacks in intervention compared to before intervention
Timepoint
before intervention, 1 month, 2 month and 3 month after intervention
Method of measurement
number of attacks
2
Description
headache severity
Timepoint
before interventio and in each headache after intervention
Method of measurement
visal analoge scale
3
Description
duration of headache
Timepoint
before intervention and in each headache after intervention
Method of measurement
per hour
Secondary outcomes
empty
Intervention groups
1
Description
Traditional medicine method is studied in this paper, this method of treatment includes cleansing, adjusting temperament and strengthen of ill member , and the two main drugs used in this study are the otryfel coriander, combined with sugar-mastic. coriander otrifel is given TDS for 1.5 month and mastic-suger BID for 3 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Clinic of Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoor Keshavarz
Street address
Tehran University of Medical Sciences , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Traditional Medicine College, Tehran University of Medical Sciences of tehran university
Full name of responsible person
Seyyed Mohammad Bagher Fazljou
Position
MD and PhD Student of Traditional Tedicine
Other areas of specialty/work
Street address
Tehran, Traditional Medicine College
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
fazljou@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional Medicine College, Tehran University of Medical Sciences of tehran university
Full name of responsible person
Seyyed Mohammad Bagher Fazljou
Position
MD and PhD Student in Traditional Medicine
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Tehran
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
fazljou@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine College, Tehran University of Medical Sciences of tehran university
Full name of responsible person
Seyyed Mohammad Bagher Fazljou
Position
MD and PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
Tehran- tehran university of medical sciences
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
fazljou@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)