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

Ain Shams University

Status and phase: Enrolling; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07022496

FMASU MD87/2023

Details and patient eligibility

About

Caffeine extracted from green tea to abort acute attack of Migraine

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Caffeine group

Experimental group

Description:

Caffeine group added to standard treatment

Treatment:

Drug: NSAID (Nonsteroidal anti-inflammatory drugs)

Drug: Paracetamol (acetaminophen)

Drug: triptans

Drug: Caffeine (200 mg)

Control group

Active Comparator group

Description:

Standard treatment (NSAIDS, Triptans, or Acetaminophen)

Treatment:

Drug: NSAID (Nonsteroidal anti-inflammatory drugs)

Drug: Paracetamol (acetaminophen)

Drug: triptans