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The effect of Saffron syrup on headache, sleep quality and fatigue in patients with migraine in clinic at the Arak University of Medical Sciences

Protocol summary

Study aim
The purpose of this study is the effect of saffron syrup on headache, fatigue and sleep disorder in patients with migraine.
Design
The clinical trial has a control group, with parallel, three-blind, randomized groups on 60 patients. A lottery was used for randomization with envelopes a and b.
Settings and conduct
This study is conducted on migraine patients who suffer from this disease for at least 6 months and have headaches at least three times a month and refer to clinics affiliated to Arak University of Medical Sciences. In this study, the participants, the researcher, the primary outcome assessor and the analyst do not know about the control and intervention groups and are blinded.
Participants/Inclusion and exclusion criteria
Having a history of migraines for 6 months, headache frequency at least three times a month, not having a hot temper, age 15 to 50 years, not taking drug prophylaxis, not pregnant and breastfeeding, not suffering from any other underlying disease
Intervention groups
Intervention group: In addition to the drugs (including nortriptyline 10 mg daily and Inderal 10 mg daily), a 240 cc bottle of saffron syrup is given to take one tablespoon every 12 hours for two months. Control group: In addition to the drugs, a placebo is prescribed in the form of one tablespoon every 12 hours, which is no different from saffron syrup in terms of appearance.
Main outcome variables
Patients are examined at the beginning of the visit and 30 and 60 days later in terms of migraine headache, fatigue and sleep quality.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160510027825N3
Registration date: 2024-08-05, 1403/05/15
Registration timing: prospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Fatemeh Mehrabi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3457 5029
Email address
f.mehrabi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Saffron syrup on headache, sleep quality and fatigue in patients with migraine in clinic at the Arak University of Medical Sciences
Public title
The effect of Saffron syrup on headache, sleep quality and fatigue in patients with migraine in clinic at the Arak University of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• Having a history of migraine for 6 months • Frequency of headaches at least three times a month • Not having a warm personality • Age 15 to 50 years
Exclusion criteria:
Use of drug prophylaxis Having another underlying disease Pregnancy and breastfeeding Having another underlying disease
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into two test and control groups, so that we make 2 envelopes containing the letters a and b. Patients who meet the conditions for entering the study will be given an envelope, if it contains the letter a, they will be in the intervention group, and if it contains the letter b, they will be in the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the participants, the researcher, the outcome assessor and the data analyst are unaware of the control and intervention groups.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ARAKMU.REC.1399.080

Health conditions studied

1

Description of health condition studied
Migraine patients who suffer from this disease for at least 6 months and have headaches at least three times per month are performed.
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
Headache score in the visual pain criterion questionnaire
Timepoint
At the beginning of treatment and 30 and 60 days after consuming saffron syrup
Method of measurement
Visual Analogue Scale

2

Description
The fatigue score in the multidimensional fatigue measurement questionnaire
Timepoint
At the beginning of treatment and 30 and 60 days after consuming saffron syrup
Method of measurement
Multidimensional fatigue assessment questionnaire

3

Description
Sleep quality score in Petersburg Sleep Quality Questionnaire
Timepoint
At the beginning of treatment and 30 and 60 days after consuming saffron syrup
Method of measurement
Petersburg Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the drugs (including nortriptyline 10 mg daily and Indral 10 mg daily), a 240 cc bottle of saffron syrup from Shakt Sanabel is given to them to consume one tablespoon every 12 hours for two months.
Category
Treatment - Drugs

2

Description
Control group: In addition to the drugs, a placebo is prescribed, which is no different from saffron syrup in terms of appearance. The placebo is made by the Sanabel company on the order of the presenters, and it will be completely similar to saffron syrup in terms of appearance and smell
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics of Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8268
Fax
+98 86 3313 3147
Email
Fmehrabi1392@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmat Pou
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8268
Email
Fmehrabi1392@gmail.com
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
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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8242
Email
Fmehrabi1392@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8242
Email
Fmehrabi1392@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8242
Email
Fmehrabi1392@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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