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A clinical trial to study the effects of two doses of the drug, amitriptyline in patients with Migraine.

Efficacy of Amitriptyline in Migraine Prophylaxis- a Comparative study of two different doses of Amitriptyline

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004302
Enrollment
82
Registered
2014-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- MIGRAINE

Interventions

Intervention1: AMITRIPTYLINE HYDROCHLORIDE 5 MILLIGRAM: used in the dosage of 5 milligram once daily per orally(bed-time)for three months Control Intervention1: AMITRIPTYLINE HYDROCHLORIDE 10 MILLIGRA

Sponsors

Sree Mookambika Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: diagnosis of Migraine either with or without aura as per International Headache Society (2013, 3rd edition) definition of Migraine, with a.more than two attacks of headache per month b.prolonged duration of headache (lasting for more than two hours) c.severe attacks of headache with substantial disability d.headache refractory to abortive drug therapy or in whom abortive drug therapy is intolerable, contraindicated or overused (more than twice a week)

Exclusion criteria

Exclusion criteria: a.Patients with other known causes of headache in addition to migraine b.Patients with known contraindications to use of Amitriptyline c.Patients with known hypersensitivity to Amitriptyline

Design outcomes

Primary

MeasureTime frame
1.Headache scoring(0-10 point numeric pain rating scale) 2.Physician Global Assessment, Response to Treatment scoringTimepoint: at the end of one, two and three months of recruitment

Secondary

MeasureTime frame
occurence of intolerable side effects- mental confusion, palpitations, hypotension, sedation, constipation, urinary retentionTimepoint: one, two and three months

Countries

India

Contacts

Public ContactSRINISH G

SREE MOOKAMBIKA INSTITUTE OF MEDICAL SCIENCES

dr.srinishg@gmail.com7639199565

Outcome results

None listed

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