The purpose of this study is to assess the efficacy of Citron juice syrup comparing with placebo and Propranolol in patients with migraine headache in a randomized clinical trial. 115 patients with a clinical diagnosis of migraine headache based on 2nd Edition of The International Headache Classification (ICHD-2) criteria were selected.At last 90 Patients will be randomized into group A (5 cc placebo syrup three times daily after a meal , for 4 weeks), group B (20 mg of Propranolol three times daily after a meal , for 4 weeks) and group C (5cc of Citron juice syrup, for 4 weeks). Patients were evaluated prior to and following 4 weeks of the intervention in terms of the frequency (per month), mean duration (hour, each attack) and mean intensity (visual analogue scale "VAS" 0-10 score) of headache attacks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031012772N1
Registration date:2015-04-20, 1394/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Gholamhossein Yousefi
Name of organization / entity
Shiraz School of Pharmacy, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71124241278
Email address
ghyousefi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research of Shiraz University of Medical Sciences
Expected recruitment start date
2013-05-06, 1392/02/16
Expected recruitment end date
2013-12-10, 1392/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Clinical trial: Citron syrup vs placebo and active controlled in treatment of migraine headache-A one month double blind study.
Public title
The effect of Citron juice syrup in Treatment of migraine Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 15-65y; Informed consent persons; 2 headache attacks or more per month; having at least one of the gastrointestinal migraine headache criteria; Not suffering from Diabetes, asthma, COPD, bradycardia, MDD and other neurologic diseases like convulsion; Not pregnancy.Exclusion criteria:Sensitivity to propranolol; use other chemical/herbal drugs within study
; Sensitivity to formulations ingredients;Unpleasant formulation to patients and desire to exclude;
Pregnancy
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2013-02-21, 1391/12/03
Ethics committee reference number
CT-91-6451
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
mean duration (hour, each attack)
Timepoint
baseline,end of follow up (4 weeks after staring intervention)
Method of measurement
questionnaire
2
Description
frequency of headache (per month)
Timepoint
baseline,4 weeks after treatment
Method of measurement
questionnaire
3
Description
mean intensity of headache attacks
Timepoint
baseline,4 weeks after treatment
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Placebo Group: Placebo syrup,15 milliliter/Tree times a day for 4 Weeks. Patients Will be Followed at Baseline and 4 Weeks after Starting Intervention.
Category
Placebo
2
Description
Intervention Group:Citron juice syrup,15 mililitr /Three times a day for 4 weeks. Patients will be Followed at Baseline and 4 after Starting Intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Jafarpour
Street address
Zand Avenue, Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamhossein Yousefi
Street address
karafarin Street, Roknabad, Quran Gate, Shiraz School of Pharmacy
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz School of Pharmacy
Full name of responsible person
Dr. Mehrnaz Jafarpour
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Karafarin street, Roknabad, Quran Gate, Shiraz School of Pharmacy
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4127
Fax
+98 71 3242 4126
Email
mjafarpoor@sums.ac.ir
Web page address
http://pharmacy.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School Of Pharmacy
Full name of responsible person
Dr.Gholamhossein Yousefi
Position
Pharm D, PhD, Academic member in the Department of Pharmaceutics, Head of the department of pharmace
Other areas of specialty/work
Street address
Karafarin street, Roknabad, Quran Gate, Shiraz School Of Pharmacy
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4128
Fax
+98 71 3242 4156
Email
ghyousefi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Dr.Mehrnaz Jafarpour
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Karafarin street, Roknabad, Quran Gate, Shiraz School of Pharmacy
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4127
Fax
+98 71 3242 4126
Email
mjafarpoor@sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)