Effect of Parcetamol in Headach

NCT ID: NCT06861738

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-04-01

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 .

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

patients will recive paracetamol

Group Type: ACTIVE_COMPARATOR

Paracetamol (acetaminophen)

Intervention Type: DRUG

oral paracetamol 500mg three times per day

groupB

patients will recive placebo

Group Type: PLACEBO_COMPARATOR

Paracetamol Placebo

Intervention Type: DRUG

placebo tab three time per day

Interventions

Paracetamol (acetaminophen)

oral paracetamol 500mg three times per day

Intervention Type: DRUG

Paracetamol Placebo

placebo tab three time per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• migrane
• any brain pathology

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Bazied Dardir mohamed

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

alaa B Dardir, residant doctor

Role: CONTACT

ala223897@gmail.com

+201155836349

Other Identifiers

parasetamol in headach

Identifier Type: -

Identifier Source: org_study_id