Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.

November 15, 2022 updated by: Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Headache in Ramadan.

Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy participants and migraine patients.

Description

Inclusion Criteria:

  • age 18-60 years.
  • expectation of fasting for at least 21 of 30 days during the month of Ramadan.
  • understand and answer the questionnaire sent out in Danish.

Exclusion Criteria:

  • non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heathy participants
Other: There is no intervention.
No intervention.
migraine patients
Other: There is no intervention.
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache frequency
Time Frame: Daily headache diary in three months.
The frequency of headaches is higher in the first half of Ramadan month compared to the last half.
Daily headache diary in three months.
Headache frequency
Time Frame: Daily headache diary in three months.
The frequency of headaches is higher in the month before Ramadan compared to the month after ramadan.
Daily headache diary in three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Faisal Mohammad Amin, Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2021

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (ACTUAL)

March 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramadan2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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