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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016071929002N1
Enrollment
62
Registered
2016-09-26
Start date
2016-07-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine

Interventions

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
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 severit
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, headach

Sponsors

Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Karimi

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences

drkarimiahmad@sbmu.ac.ir+98 21 8877 2521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026