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Evaluation of the effect of PSM® ointment in refractory headache to treatment

Evaluation of the effect of PSM® ointment along with common therapies in patients with refractory headache to treatment

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201228049868N1
Enrollment
60
Registered
2021-01-19
Start date
2021-01-03
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Refractory headache. Chronic migraine

Interventions

Intervention 1: Intervention group: Ointment containing nortriptyline, prednisolone, aspirin and biperiden in a base of eucerin along with common therapy. Intervention 2: Control group: Eucerin ointme

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Refractory headache more than 15 days a month for three consecutive months

Exclusion criteria

Exclusion criteria: Warning signs associated with increased intracranial pressure Abnormal brain imaging Focal brain lesions Infectious CNS disease Psychiatric diseases Symptoms of tumors and cerebral occupying lesions Drug abuse Pregnant and lactating women Elective discontinuation of the study Skin reaction to the ointment Exacerbation of symptoms or any new neurological complications

Design outcomes

Primary

MeasureTime frame
Headache severity based on Visual Analogue Scale. Timepoint: Baseline and after one month. Method of measurement: Questionnaire.;Duration of headache. Timepoint: Baseline and after one month. Method of measurement: Questionnaire.;Frequency of headache. Timepoint: Baseline and after one month. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Adverse effects. Timepoint: Baseline and after one month. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Mohammad Mousavi Mirzaei

Birjand University of Medical Sciences

mousavim903@bums.ac.ir+98 56 3162 6020

Outcome results

None listed

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