Evaluation of therapeutic efficacy of apple-quince syrup formulation compared to placebo in the treatment of patients with migraine headache: a double-blind randomized clinical trial
The purpose of this study is to assess the therapeutic efficacy of apple-quince syrup compared to placebo in patients with migraine headache. A neurologist selects patients from those who are aged from 18 to 60 years and are considered to be affected by by migraine according to the International Classification of Headache Disorders (ICHD) criteria, the third edition. Subsequently, 62 patients are selected and randomly divided into two treatment groups. One group keeps an apple-quince syrup diet and the other group keeps a placebo diet in which 15 ml syrup is consumed, three times in a day after each meal for 4 weeks. Patients are evaluated before and four weeks after treatment . Two groups are evaluated finally in terms of the number of headaches per month, headache intensity and the duration of headache, according to the pain self-efficacy score. The history of diabetes, hypertension and addiction are important exclusion criteria. The random allocation of patients to intervention and control group will be based on the block randomization method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071929002N1
Registration date:2016-09-26, 1395/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-26, 1395/07/05
Registrant information
Name
Ahmad Karimi
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 2314
Email address
drkarimiahmad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic efficacy of apple-quince syrup formulation compared to placebo in the treatment of patients with migraine headache: a double-blind randomized clinical trial
Public title
Evaluating the effect of apple-quince syrup on migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Confirming the existence of migraine according to the International Classification of Headache Disorders (ICHD), the third edition, by a neurologist; Aged 18 to 60 years.
Exclusion Criteria: History of unknown abdominal pain, History of acute abdomen surgery, History of renal and hepatic disease, History of obstructive gastrointestinal disease, History of malignancy, Existence of warning signs such as GI bleeding, Weight loss and anemia, Diabetes mellitus (fasting blood sugar test above 110 mg/dl), HTN, Addiction to opioids and stimulants, Alcohol consumption, Patients who do not want to continue the research, Patients who are non-compliant with taking the prescribed drug, Unpredictable complications leading to drug intolerance such as idiosyncratic complications, Using medical or traditional laxatives and any significant change in lifestyle affecting headache of the patient during intervention.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The random allocation of patients to intervention and control group will be based on the block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to the Ayatollah Taleghani Hospital, Martyr Arabi Street, Yemen Street, Martyr Chamran Highway
City
Tehran
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SBMU.REC.1395.1
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache Severity
Timepoint
The Form of "Evaluation of the Severity, Duration and Frequency of Migraine Headaches" is delivered to each patient. During the four weeks prior to the intervention, each patient completes the form. Then the drug or placebo is given to the patient for 4 weeks as the treatment while the form is being completed. Also, during 4 weeks after the intervention, information is recorded. So, the Form is completed in three phases (4 weeks before intervention, during treatment and 4 weeks after intervention) by the patient. Pain intensity for each patient is determined and recorded by Visual Analogue Scale (VAS) criteria.
Method of measurement
visual scale of ten
2
Description
Headache Frequency
Timepoint
The Form of "Evaluation of the Severity, Duration and Frequency of Migraine Headaches" is delivered to each patient. During the four weeks prior to the intervention, each patient completes the form. Then the drug or placebo is given to the patient for 4 weeks as the treatment while the form is being completed. Also, during 4 weeks after the intervention, information is recorded. So, the Form is completed in three phases (4 weeks before intervention, during treatment and 4 weeks after intervention) by the patient.
Method of measurement
Recording the headache frequency in the questionnaire
3
Description
Headache Duration
Timepoint
The Form of "Evaluation of the Severity, Duration and Frequency of Migraine Headaches" is delivered to each patient. During the four weeks prior to the intervention, each patient completes the form. Then the drug or placebo is given to the patient for 4 weeks as the treatment while the form is being completed. Also, during 4 weeks after the intervention, information is recorded. So, the Form is completed in three phases (4 weeks before intervention, during treatment and 4 weeks after intervention) by the patient
Method of measurement
Recording the headache duration by patient in the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Apple-quince syrup, 15 ml three times daily after meals for 4 weeks. Patients will be evaluated at the baseline and 4 weeks after starting intervention in terms of headache severity, headache frequency and headache duration. To make apple-quince syrup, equal volumes of apple and quince juice will be mixed and boiled until get it thick (one-seventh of the initial volume).
Category
Placebo
2
Description
Placebo Group: Placebo syrup, 15 ml three times daily after meals for 4 weeks. Patients will be evaluated at the baseline and 4 weeks after starting intervention in terms of headache severity, headache frequency and headache duration. To make placebo, sugar, glycerin and water will be mixed and boiled until get it thick.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Center for Headache of Bagheiyatallah Azam Hospital
Full name of responsible person
Ahmad Karimi
Street address
Sheikh Bahaie intersection, Molla Sadra street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somaye Esmaili
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Karimi
Position
Ph.D Student of Traditional Medicine
Other areas of specialty/work
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
drkarimiahmad@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Movahhed
Position
Assistant professor
Other areas of specialty/work
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
m_movahhed@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Karimi
Position
Ph.D. Student of Traditional Medicine
Other areas of specialty/work
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
drkarimiahmad@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)