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

NCT07022496 | Recruiting Phase 4 DMC

• 1 other identifier: FMASU MD87/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Caffeine extracted from green tea to abort acute attack of Migraine

Conditions

Migraine; Migraine Disease; Migraine Headache; Migraine Headache, With or Without Aura; Migraine, Acute

Outcome Measures

Primary Outcomes (1)

• To reduce the severity of migraine attack

  using Visual analogue scale

  Three years

Secondary Outcomes (1)

• 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

Study Arms (2)

Caffeine group

EXPERIMENTAL

Caffeine group added to standard treatment

Drug: Caffeine (200 mg); Drug: triptans; Drug: NSAID (Nonsteroidal anti-inflammatory drugs); Drug: Paracetamol (acetaminophen)

Control group

ACTIVE COMPARATOR

Standard treatment (NSAIDS, Triptans, or Acetaminophen)

Drug: triptans; Drug: NSAID (Nonsteroidal anti-inflammatory drugs); Drug: Paracetamol (acetaminophen)

Interventions

Caffeine (200 mg) DRUG

caffeine tablets

Caffeine group

triptans DRUG

Sumatriptan

Caffeine group; Control group

NSAID (Nonsteroidal anti-inflammatory drugs) DRUG

Aspirin 250 mg, 81 mg, 75 mg

Caffeine group; Control group

Paracetamol (acetaminophen) DRUG

Paracetamol 250 mg

Caffeine group; Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university

Cairo, 11769, Egypt

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Caffeine; Tryptamines; Anti-Inflammatory Agents, Non-Steroidal; Acetaminophen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Acetanilides; Anilides; Amides; Aniline Compounds

Central Study Contacts

Nourhan Nader Elguindy, Masters degree

CONTACT

00201128215952; nourhanelguindy@gmail.com

Diaa Marzouk Abdelhamid, PhD

CONTACT

00201200678440; diaamarzouk@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: June 15, 2025
• Study Start: April 26, 2023
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)