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

Phase 3

Recruiting

• Conditions: Refractory headache.; Chronic migraine; 8A80.2

• Registration Number: IRCT20201228049868N1
• Lead Sponsor: Birjand University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse effects. Timepoint: Baseline and after one month. Method of measurement: Questionnaire.