The aim of this study is to determine the Effectiveness of topical formulation on reducing dandruff symptoms
Design
Two arm parallel double blinded randomised clinical trial phase 2-3 with 2 groups; Control group and Intervention group.
Settings and conduct
All patients referred to medical office of Ahvaz, Iran, who have inclusion criteria were assigned randomly in one of the treatment methods for 4 weeks. These patients randomly receive a bottle containing a herbal formulation or drug.Unique codes, which is generated by the software, will be used on the drug boxes. During the research, the randomization list is held by the statistic consultant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Presence of dandruff; age between 18 to 60 years; written census to participate in the study. Exclusion criteria: To have any history of hypersensitivity to Azol' s or anti-fungal drugs; Age less than 18 or above 60; Pregnancy or breast feeding; Having liver diseases or Porphyria; Alcohol addiction; History of skin cancer; Consumption any immunosuppressive drug 4 weeks before the study and steroids 2 weeks before study.
Intervention groups
Intervention: Herbal solution ; First washing head for 3 min. with 40 ml of solution then rinse and wash the head by shampoo (keeping the foam for 3 min) once every 3 days for 10 days. After that repeating the process once every 4 days for another 20 days.
Control group: Ketoconazol (2%) shampoo; First washing head for 3 min. with 40 ml of solution then rinse and wash the head by shampoo (keeping the foam for 3 min) once every 3 days for 10 days. After that repeating the process once every 4 days for another 20 days.
Main outcome variables
Inflammation and Saling score of head
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041466N2
Registration date:2019-05-23, 1398/03/02
Registration timing:prospective
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Ali Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 8149
Email address
ali.aghaei110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and Clinical Evaluation Of Efficacy Of Anti-dandruff Herbal Shampoo In Comparison With Ketoconazole
Public title
Preparation and Clinical Evaluation Of Efficacy Of Anti-dandruff Herbal Shampoo In Comparison With Ketoconazole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of dandruff
age between 15 to 50 years
written census to participate in the study
Exclusion criteria:
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com)
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
-61357-15794
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.AJUMS.REC.1398.164
Health conditions studied
1
Description of health condition studied
Dandruff
ICD-10 code
Seborrhoea
ICD-10 code description
L-21.0
Primary outcomes
1
Description
Inflammation and redness of skulp
Timepoint
Before intervention, 4th weeks after start of intervention and 4 weeks after end of intervention.
Method of measurement
Observation and physical exam
2
Description
Scaling score
Timepoint
Before intervention, 4th weeks after start of intervention and 4 weeks after end of intervention.
Method of measurement
Observation and physical exam
Secondary outcomes
1
Description
Drug side effects
Timepoint
During the study
Method of measurement
Patients' report
Intervention groups
1
Description
Intervention group: Herbal shampoo; First washing head for 3 min. with 40 ml of solution then rinse and wash the head by shampoo (keeping the foam for 3 min) once every 3 days for 10 days. After that repeating the process once every 4 days for another 20 days.
Category
Treatment - Drugs
2
Description
Control group: Washing with Ketoconazol (2%) shampoo; First washing head for 3 min. with 40 ml of solution then rinse and wash the head by shampoo (keeping the foam for 3 min) once every 3 days for 10 days. After that repeating the process once every 4 days for another 20 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
مطب خصوصی
Full name of responsible person
فاروق آقایی
Street address
koote abdollah
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 8149
Email
ali.aghaei110@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badavi
Street address
Ahvaz Jundishapur University of medical Sciences, Golestan road.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
Badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3333 8149
Fax
Email
ali.aghaei110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3333 8149
Fax
Email
ali.aghaei110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Aghaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3333 8149
Fax
Email
ali.aghaei110@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data will be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results
To whom data/document is available
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month