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IRCT20201228049868N1 IRCT 2021-01-19 Birjand University of Medical Sciences Evaluation of the effect of PSM® ointment in refractory headache to treatment ®PSM Evaluation of the effect of PSM® ointment along with common therapies in patients with refractory headache to treatment 2021-01-03 anticipated 60 Complete https://irct.ir/trial/53343 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned as a random permutation block in two groups. Randomization was using random number generation. Thirty random numbers from 1 to 60 and these people are our intervention group, Blinding description: All of the steps will be covered by the patient, physician and evaluators. 3 Refractory headache. 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 ointment along with common therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Seyyed Mohammad Mousavi Mirzaei
Razi Hospital, Ghaffari Street
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3162 6020 mousavim903@bums.ac.ir Birjand University of Medical Sciences scientific Seyyed Mohammad Mousavi Mirzaei
Razi Hospital, Ghaffari Street
Birjand Iran (Islamic Republic of) 9717844471 +98 56 3162 6020 mousavim903@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Refractory headache more than 15 days a month for three consecutive months no limit no limit Both 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 8A80.2 Chronic migraine Treatment - Drugs Treatment - Drugs Intervention group: Ointment containing nortriptyline, prednisolone, aspirin and biperiden in a base of eucerin along with common therapy Control group: Eucerin ointment along with common therapy 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. Adverse effects. Timepoint: Baseline and after one month. Method of measurement: Questionnaire. Birjand University of Medical Sciences Approved 2020-10-12 Ethics Committee of Birjand University of Medical Sciences Birjand University of Medical Sciences , Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)