[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604319":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":50,"overallOfficials":29,"centralContacts":60,"locations":29,"responsibleParty":66,"collaborators":29,"id":70,"slug":29,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":29,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":29,"enrollmentInfo":77,"targetDuration":29,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":88,"whyStopped":29,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":29},{"fullName":5,"class":6},"Fayoum University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":29},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"migraine intensity using The visual analog scale (VAS score)","To evaluate changes in migraine intensity using the visual analog scale (VAS score) in both groups which is one of the pain rating scales. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.","3 months",{"measure":14,"description":15,"timeFrame":12},"migraine duration","To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better.",{"measure":17,"description":18,"timeFrame":12},"MIDAS score (Migraine Disability Assessment) Score","To evaluate changes in MIDAS score (Migraine Disability Assessment) in both groups. Which is a validated, 5-item questionnaire designed to quantify the severity of headache-related disability over the past three months by assessing missed days and reduced productivity in work\u002Fschool, household chores, and social\u002Ffamily activities. The total score, which can range from 0 to 270, indicates the overall impact of migraines on daily functioning, with higher scores signifying greater disability. MIDAS score. Disability. MIDAS grade ; 0-5. Little or no disability. I ; 6-10. Mild disability. II ; 11-20. Moderate disability.",[20,23,26],{"measure":21,"description":22,"timeFrame":12},"changes in the frequency of migraine attacks","Number of participants with the change in the frequency of migraine attacks. Less frequency, the better.",{"measure":24,"description":25,"timeFrame":12},"side effect profile","To calculate the % of patients who didn't experience side effects of treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction.",{"measure":27,"description":28,"timeFrame":12},"patient satisfaction","To calculate the % of patients who were satisfied with the treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","Primary Objective:\n\n\\- To compare the reduction in the frequency of migraine attacks between patients receiving conventional prophylactic therapy and those receiving a nutraceutical combination.\n\nSecondary Objectives:\n\n* To evaluate changes in migraine intensity (VAS score), duration, and MIDAS score.\n* To assess the side effect profile and patient satisfaction with both interventions.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Group 1","ACTIVE_COMPARATOR","Conventional Therapy",[43],"Drug: Propranolol 80 mg",{"label":45,"type":46,"description":47,"interventionNames":48},"Group 2","PLACEBO_COMPARATOR","Nutraceutical Therapy",[49],"Drug: Magnesium 400Mg",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":29},"DRUG","Propranolol 80 mg","Propranolol 40-80 mg\u002Fday",[39],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":29},"Magnesium 400Mg","Magnesium 400 mg daily",[45],[61],{"name":62,"role":63,"phone":64,"phoneExt":29,"email":65},"Marwa Kamal Tolba, Associate professor","CONTACT","01067789982","mka05@fayoum.edu.eg",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Marwa Ahmed Kamal Tolba","Associate professor clinical pharmacy department -faculty of pharmacy- fayoum university","100604319",false,"NCT07147972","Comparative Study of Nutraceuticals vs. Conventional Prophylactic Therapy in the Management of Migraine","Inclusion Criteria:\n\n* Adults aged 18-60 years\n\n  * \\- Diagnosed with episodic migraine (ICHD-3 criteria)\n  * \\- ≥4 migraine attacks\u002Fmonth for the past 3 months\n  * \\- Willing to provide informed consent\n\nExclusion Criteria:\n\n* • - Chronic migraine (\\>15 headache days\u002Fmonth)\n\n  * \\- Use of other prophylactic treatments in past month\n  * \\- History of secondary headaches\n  * \\- Pregnancy or breastfeeding\n  * \\- Significant renal, hepatic, or cardiac disease","ALL","18 Years",{"count":78,"type":79},100,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Recent evidence suggests that nutraceuticals like magnesium, riboflavin, and coenzyme Q10 may provide a safer alternative. This study aims to compare the efficacy and tolerability of these two approaches.",[85,86],"Migraine","Nutraceuticals",[85,86],"NOT_YET_RECRUITING","2025-08-27",{"date":91,"type":92},"2025-08-29","ACTUAL",{"date":94,"type":79},"2025-08-20",{"date":96,"type":79},"2026-02-01",{"name":5,"class":6}]