HeadacheNCT04804995
Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.
An observational study of Headache and Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- How many people
- 134 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Mar 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Healthy participants and migraine patients.
Who may be able to join
- 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.
Who cannot join
- non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Being tested
- There is no intervention.
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Heathy participants | Not described Receives: Other: There is no intervention. | |
| migraine patients | Not described Receives: Other: There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
The frequency of headaches is higher in the first half of Ramadan month compared to the last half.
Measured: Daily headache diary in three months.
Headache frequency
The frequency of headaches is higher in the month before Ramadan compared to the month after ramadan.
Measured: Daily headache diary in three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start16 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
- Investigators
- Faisal Mohammad Amin, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804995
- Sponsor's protocol ID
- Ramadan2021
- Status last verified
- Nov 2022
- First submitted
- 16 Mar 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache in Ramadan.
- ClinicalTrials.gov ID
- NCT04804995
- Acronym / sponsor ID
- Ramadan2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heathy participants | – | Other: There is no intervention. |
| migraine patients | – | Other: There is no intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy participants and migraine patients.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention.No intervention. | Other | Heathy participants, migraine patients |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal Mohammad Amin principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: Daily headache diary in three months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.