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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.

To Evaluate efficacy and tolerability of Vasograin ( Ergotamine 1 mg plus Paracetamol 250 mg plus Prochlorperazine 2.5 mg plus Caffeine 100 mg) in adult patients in the treatment of acute migraine: An Open label, Non-randomized, Single arm Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068686
Enrollment
1000
Registered
2024-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G430- Migraine without aura

Interventions

Intervention1: Vasograin Tablets (Ergotamine 1 mg + Paracetamol 250 mg + Prochlorperazine 2.5 mg + Caffeine 100 mg): 1 tablet at the start of migraine attack
1 additional tablet every 2 hours, if needed for full relief (Maximum Dose: not more than 4 tablets per day and 10 tablets within a week) Total duration 7 days Control Intervention1: Not applicable: N

Sponsors

Cadila Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pain relief after use of VasograinTimepoint: Pre dose, post dose- 2 hours 4 hours, 24 hours and 48 hours

Secondary

MeasureTime frame
Decrease in pain intensity after use of Vasograin Sustained pain free interval after use of Vasograin Proportion of patients requiring rescue medication within 24 hours. 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

Countries

India

Contacts

Public ContactPravin Goswami

Zyfis Lifesciences Private Limited

dimple.shah@zyfis.in8866662183

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026