To observe safety of Vasograin (a combination of Ergotamine, Paracetamol, Prochlorperazine, and Caffeine) for treating migraines in adults: an open study where all participants receive the same treatment.
Phase 4
- Conditions
- Health Condition 1: G430- Migraine without aura
- Registration Number
- CTRI/2024/06/068686
- Lead Sponsor
- Cadila Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
1. Patients of both genders.
2. Age older or equal to 18 years.
3. Patients which are experiencing migraine headache as per physician’s clinical judgement.
4. Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF).
Exclusion Criteria
1. Hypersensitivity to any of the study drugs.
2. Pregnant or lactating females or female using an oral contraceptives.
3. Patients with clinically significant hepatic or renal disease.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain relief after use of VasograinTimepoint: Pre dose, post dose- 2 hours 4 hours, 24 hours and 48 hours <br/ ><br>
- Secondary Outcome Measures
Name Time Method Decrease in pain intensity after use of Vasograin <br/ ><br>Sustained pain free interval after use of Vasograin <br/ ><br>Proportion of patients requiring rescue medication within 24 hours. <br/ ><br>Relief from migraine associated symptoms like Nausea/vomiting, Photophobia & Phonophobia: the proportion of patients who are free from migraine associated symptoms like nausea/vomiting, photophobia & phonophobiaTimepoint: At Base line, 2 hrs, 4 hrs, 24 hrs & 48 hrs post dose