Actively Recruiting
Assessment of Oral Caffeine Intake in Reducing the Severity of Acute Migraine Attack Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals: A Randomized Controlled Trial
Led by Ain Shams University · Updated on 2025-06-15
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of caffeine extracted from green tea to reduce the severity of acute migraine attacks in adults aged 18 to 60 years. This Phase 4 randomized controlled trial compares the effects of oral caffeine intake with standard treatments for migraines, such as NSAIDs, triptans, or acetaminophen. The study aims to understand if adding caffeine tablets can help lessen migraine pain intensity measured by the Visual Analogue Scale (VAS). Participants are randomly assigned to either receive caffeine tablets (200 mg) in addition to their standard migraine treatment or to continue with standard treatment alone. The trial is conducted at the Headache and Neurology Outpatients Clinic of Ainshams University Hospitals and lasts for three years. The caffeine group receives caffeine tablets alongside their usual medications, while the control group receives only the standard migraine medications. During the study, participants will be monitored for changes in migraine severity and pain reduction at regular intervals using the VAS score. Researchers will assess the effectiveness of caffeine in easing migraine attacks over the three-year period. Safety and adherence to treatments will be observed throughout, with ongoing evaluations to ensure participant well-being and to record any changes in migraine symptoms.
CONDITIONS
Brief Title
Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 60 years
- Diagnosed with migraine with aura, migraine without aura, episodic or chronic migraine according to ICHD-3 criteria
You will not qualify if you...
- History of cardiac dysrhythmia, hypertension, or ischemic heart disease
- Active peptic ulcer disease or inflammatory bowel disease
- Obsessive compulsive disorder
- Pregnancy or breastfeeding
- Renal failure or hepatic failure
- Sleep disorder or mental retardation
- History of substance abuse preventing cooperation
- Headache caused by cluster headache, trigeminal neuralgia, glossopharyngeal neuralgia, trauma, cranial disorder, vascular disorder, infection, or mass lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive either oral caffeine tablets added to standard treatment or standard treatment alone to reduce the severity of acute migraine attacks.
Visits occur as needed during migraine attacks throughout the treatment period
Trial Site Locations
Total: 1 location
1
Ainshams university
Cairo, Egypt, 11769
Actively Recruiting
Research Team
N
Nourhan Nader Elguindy, Masters degree
D
Diaa Marzouk Abdelhamid, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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