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IRCT2016071929002N1 IRCT 2016-09-26 Vice chancellor for research, Shahid Beheshti University of Medical Sciences Evaluating the effect of apple-quince syrup on migraine headache 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 2016-07-22 anticipated 62 Complete https://irct.ir/trial/23404 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The random allocation of patients to intervention and control group will be based on the block randomization method. N/A Migraine. Intervention 1: 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). Intervention 2: 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.
public Ahmad Karimi
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
Tehran Iran (Islamic Republic of) +98 21 8877 2521 drkarimiahmad@sbmu.ac.ir School of Traditional Medicine, Shahid Beheshti University of Medical Sciences scientific Mina Movahhed
No. 8, Shams Alley, Opposite Tavanir, Valiasr Street
Tehran Iran (Islamic Republic of) +98 21 8877 2521 m_movahhed@sbmu.ac.ir School of Traditional Medicine, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 60 years Both G43 Migraine Placebo Placebo 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). 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. 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. 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. 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. Vice chancellor for research, Shahid Beheshti University of Medical Sciences Approved 2016-07-03 Ethics committee of Shahid Beheshti University of Medical Sciences Next to the Ayatollah Taleghani Hospital, Martyr Arabi Street, Yemen Street, Martyr Chamran Highway Tehran Iran (Islamic Republic of)