A clinical trial to compare the effects of riboflavin and propranolol in preventive therapy of migraine

Phase 3

Completed

• Registration Number: CTRI/2010/091/000539
• Lead Sponsor: Dr. Y K Gupta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.Patient of either sex between age group18-65 years who have not received any drug for migraine prophylaxis before.
2.Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study.
3.More than four migraine episodes per month but no greater than 15 headache days (migraine and non-migraine) in one month during the baseline phase. There should be a gap of at least 48 hours between two episodes. Frequency of non-migraine headaches should be no more than 6 episodes per month.
4.No significant abnormalities on clinical examination at baseline.
5.Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception during the complete study period.
6.Willing to provide informed consent.
7.Patients able to maintain a headache diary.

Exclusion Criteria

1.Patients with headaches other than migraine who cannot differentiate migraine from other headaches.
2.Onset of migraine after age of 50 years
3.Patients who have taken antipsychotics or antidepressants during the previous 3 months.
4.Patients who abuse alcohol or other drugs.
5.Patients who use drugs excessively for headache (more than 10 days per month).
6.Pregnant or lactating women
7.Patients with heart or kidney diseases, asthma or diabetes or otherwise unhealthy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified