Effect of Parcetamol in Headach

Phase 3

Not yet recruiting

• Conditions: Headache
• Interventions: Drug: Paracetamol (acetaminophen); Drug: Paracetamol Placebo

• Registration Number: NCT06861738
• Lead Sponsor: Assiut University

Brief Summary

Tension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headaches per month), and chronic TTH (15 headache days a month or more). Paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.Objectives To assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic TTH in adults.

Detailed Description

Headaches are a commonly reported problem in community-based surveys worldwide. The lifetime prevalence of headache is estimated to be greater than 90% , and the annual prevalence rate is estimated to be 46% in the general adult population . Variations in reported prevalence may result from differences in study design, population, inclusion or exclusion of cases of infrequent episodic TTH, overlap with probable migraine, cultural and environmental differences, or even genetic factors . TTH is more common than migraine, a finding replicated across the work.

The management of people with headaches is largely neglected , and may be fragmented by the involvement of clinicians from different medical specialities (neurology; ear, nose and throat; ophthalmology; psychiatry). Because headache is rarely life-threatening and headache pain is generally mild to moderate in intensity, people often self medicate and do not seek formal care from health services .

Headache can be either primary (no underlying cause) or secondary (due to other systemic or local causes) . TTH belongs to the group of primary headaches and is seen in nearly one-third of people experiencing headaches; the large number of people affected imposes a significant burden on the healthcare system. Generally, episodes of TTH are mild to moderate in intensity, and self limiting, but in a small group of people they may be more severe and disabling . People with longer lasting or more severe headaches may seek help in a clinical setting, but the majority of people do not do so, resulting often in inadequate and inappropriate management .

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-01
• Last Update Submitted: 2025-03-01
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• both sex
• 18 years old to 65 years
• free ct brain

Exclusion Criteria

• migrane
• any brain pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Paracetamol (acetaminophen)	patients will recive paracetamol
groupB	Paracetamol Placebo	patients will recive placebo

Primary Outcome Measures

Name	Time	Method
pain score VAS score	24 hours	VAS Score for pain