Efficacy of Riboflavin and Amitriptyline in Migraine Attack

Efficacy of Riboflavin and Amitriptyline in Frequency and Intensity of migraine Attack in Patients with Migraine Headache

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230823059240N1

Enrollment

Registered

2023-12-18

Start date

2023-09-11

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Migraine Headche. Migraine

Interventions

Intervention 1: Intervention group: this study, riboflavin (from Flaviran brand) has administrated to patients at a dose of 200 mg divided into two doses of 100 mg (every 12 hours) up to 3 months (sam

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Migraine with or without aura based on IHS criteria Migraine history since the last year Migraine with frequency of 2 to 8 times per month or at least 2 days of headache per month Patient's age should be between 18 to 65 years old The migraine headache must be completely distinguished from other types

Exclusion criteria

Exclusion criteria: Tension headache or other types more than 15 times a month Daily recipient of painkillers more than 15 times a month Patients who received more than 3 complete prophylaxis trials and did not respond to prophylactical treatment Pregnancy or planning for pregnancy Taken another prophylaxis medicine for less than a month Drug abruptions (drug reaction) Patients who don't want to continue the treatment or stop the medication receipt Patients who referred not for further evaluation

Design outcomes

Primary

Measure	Time frame
Comparison of effects on headache indices (duration, severity of clinical symptoms, and frequency of attacks) in riboflavin and amitriptyline groups and comparison of riboflavin and amitriptyline headache indices in the period of one, three months from the start of treatment and investigation of side effects caused by Taking study drugs. Timepoint: In this study, the headache indices in two groups of riboflavin and amitriptyline are investigated in the period of one and three month after starting the treatment. Method of measurement: In both groups, based on a checklist of patients' demographic information, as well as information related to occupation, duration of headache, type of previously used medication, headache intensity (PAIN SCALE), frequency of attacks per month, number of days of attack and co-morbidity of DM, HTN, VASCULAR DISORDER, PSYCHIATRIC DISORDER, GI DISORDER) are fulfilled by patients in both groups. Patients in the first group (A) has administrated riboflavin at a dose of 100 mg twice a day, and the other group (B) has administrated amitriptyline at a single dose of 25 mg. Then both groups are re-evaluated again after one and three months later in terms of headache indicators. Also, the drug side effects considered in the study including (diarrhea, nausea, vomiting and polyuria) are investigated.	—

Measure

Time frame

Comparison of effects on headache indices (duration, severity of clinical symptoms, and frequency of attacks) in riboflavin and amitriptyline groups and comparison of riboflavin and amitriptyline headache indices in the period of one, three months from the start of treatment and investigation of side effects caused by Taking study drugs. Timepoint: In this study, the headache indices in two groups of riboflavin and amitriptyline are investigated in the period of one and three month after starting the treatment. Method of measurement: In both groups, based on a checklist of patients' demographic information, as well as information related to occupation, duration of headache, type of previously used medication, headache intensity (PAIN SCALE), frequency of attacks per month, number of days of attack and co-morbidity of DM, HTN, VASCULAR DISORDER, PSYCHIATRIC DISORDER, GI DISORDER) are fulfilled by patients in both groups. Patients in the first group (A) has administrated riboflavin at a dose of 100 mg twice a day, and the other group (B) has administrated amitriptyline at a single dose of 25 mg. Then both groups are re-evaluated again after one and three months later in terms of headache indicators. Also, the drug side effects considered in the study including (diarrhea, nausea, vomiting and polyuria) are investigated.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Gorji

Qazvin University of Medical Sciences

r.gorji@qums.ac.ir+98 28 3335265

Outcome results

None listed

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