Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT01148303
Eligibility Criteria:
Inclusion Criteria:
* Age 18 -65.
* Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
* Patient states that he/she typically suffered from headache during fasting in the past.
Exclusion Criteria:
* Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract
* Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
* Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control
* Severe hepatic dysfunction
* Estimated renal creatinine clearance \<30 ml/min
* History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease
* Congestive heart failure
* Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
* Cancer or any other malignant disease
* History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01148303
Study Brief:
Protocol Section:
NCT01148303