Determining the effect of PSM® ointment along with common therapies in patients with refractory headache
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 60 patients. Patients will be assigned as a random permutation block in two groups.
Settings and conduct
We will evaluate patients referred to a neurology clinic of Razi Hospital in Birjand with refractory headache more than 15 days a month for three consecutive months of headache.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
Headache severity based on Visual Analogue Scale, Duration of headache, Frequency of headache
General information
Reason for update
Acronym
®PSM
IRCT registration information
IRCT registration number:IRCT20201228049868N1
Registration date:2021-01-19, 1399/10/30
Registration timing:registered_while_recruiting
Last update:2021-01-19, 1399/10/30
Update count:0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
Seyyed Mohammad Mousavi Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 6020
Email address
mousavim903@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-03, 1399/10/14
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of PSM® ointment along with common therapies in patients with refractory headache to treatment
Public title
Evaluation of the effect of PSM® ointment in refractory headache to treatment
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
All of the steps will be covered by the patient, physician and evaluators.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.BUMS.REC.1399.334
Health conditions studied
1
Description of health condition studied
Refractory headache
ICD-10 code
8A80.2
ICD-10 code description
Chronic migraine
Primary outcomes
1
Description
Headache severity based on Visual Analogue Scale
Timepoint
Baseline and after one month
Method of measurement
Questionnaire
2
Description
Duration of headache
Timepoint
Baseline and after one month
Method of measurement
Questionnaire
3
Description
Frequency of headache
Timepoint
Baseline and after one month
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Adverse effects
Timepoint
Baseline and after one month
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Ointment containing nortriptyline, prednisolone, aspirin and biperiden in a base of eucerin along with common therapy
Category
Treatment - Drugs
2
Description
Control group: Eucerin ointment along with common therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Razi Hospital
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Email
mousavim903@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6020
Email
mousavim903@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6020
Email
mousavim903@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6020
Email
mousavim903@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available