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NCT Number: NCT06861738

Effect of Parcetamol in Headach

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • migrane
  • any brain pathology

Treatment and study plan

Paracetamol (acetaminophen)

Drug

oral paracetamol 500mg three times per day

Paracetamol Placebo

Drug

placebo tab three time per day

Primary outcomes

  1. pain score VAS score

    Time frame: 24 hours

    VAS Score for pain

Study contacts

Contact information is provided by the study sponsor or research team.

alaa B Dardir, residant doctor

CONTACT

[email protected]

+201155836349

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comaring the Effect of Paracetamol in Tratment of Headach

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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