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

Phase 4

Recruiting

• Conditions: Migraine; Migraine Headache; Migraine, Acute; Migraine Disease; Migraine Headache, With or Without Aura
• Interventions: Drug: Caffeine (200 mg); Drug: triptans; Drug: Paracetamol (acetaminophen); Drug: NSAID (Nonsteroidal anti-inflammatory drugs)

• Registration Number: NCT07022496
• Lead Sponsor: Ain Shams University

Brief Summary

Caffeine extracted from green tea to abort acute attack of Migraine

Detailed Description

Caffeine tablets extracted from green tea can be used as caffeinated drinks to decrease intensity of migraine attacks

Study Timeline

• Study Start: 2023-04-26
• Study First Submitted: 2024-12-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-07
• Last Update Submitted: 2025-06-07
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients suffering from migraine with aura, migraine without aura, episodic, and chronic migraine according to ICHD-3 diagnosis will be legible for the study.

Exclusion Criteria

Patients who have history of any cardiac dysrhythmia, hypertension, ischemic heart disease, active peptic ulcer disease, inflammatory bowel disease, obsessive compulsive disorder, pregnancy, breast-feeding, renal failure, hepatic failure, sleep disorder, mental retardation, and history of substance abuse that prevent them from cooperating with us during the study Patients who had headache due to: Cluster headache, trigeminal neuralgia, glossopharyngeal neuralgia, headache secondary to trauma, cranial disorder, vascular disorder, infection, or mass lesion, will also be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeine group	Caffeine (200 mg)	Caffeine group added to standard treatment
Control group	Paracetamol (acetaminophen)	Standard treatment (NSAIDS, Triptans, or Acetaminophen)
Caffeine group	triptans	Caffeine group added to standard treatment
Caffeine group	Paracetamol (acetaminophen)	Caffeine group added to standard treatment
Caffeine group	NSAID (Nonsteroidal anti-inflammatory drugs)	Caffeine group added to standard treatment
Control group	triptans	Standard treatment (NSAIDS, Triptans, or Acetaminophen)
Control group	NSAID (Nonsteroidal anti-inflammatory drugs)	Standard treatment (NSAIDS, Triptans, or Acetaminophen)

Primary Outcome Measures

Name	Time	Method
To reduce the severity of migraine attack	Three years	using Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of oral caffeine in reducing pain associated with acute migraine attacks among patients attending Headache Clinic, Ain Shams University hospital via Visual analogue scale	Three year	To assess the pain reduction through visual analogue scale

Trial Locations

Locations (1)

Ainshams university; 🇪🇬 Cairo, Egypt