The aim of this study is to determine the Effectiveness of topical herbal formulation on reducing mild to moderate acne 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 who have inclusion criteria were assigned randomly in one of the treatment methods for 8 weeks. These patients randomly receive a package containing a herbal formulation or clindamycin .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, 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.then response of treatment will be evaluated at week 4, 8, 12.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with mild to moderate acne, defined as global acne grading system (GAGS) scale,patients who have not used topical anti acne drugs in the recent month,patients who have not used oral anti acne drugs in past 2 months Exclusion criteria:pregnancy,had a skin disease,were known to be allergic or sensitive to any of the study medications,lactating.
Intervention groups
"Control group": Patients who receive topical Gel of clindamycin 1% Najo after washing with antibacterial soap 3times in day for two months "Intervention group": Patients who receive topical herbal formulation made in ahvaz pharmacy school after washing with antibacterial soap 3 times in day for two months
Main outcome variables
Total lesion count and acne severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041466N3
Registration date:2020-08-31, 1399/06/10
Registration timing:registered_while_recruiting
Last update:2020-08-31, 1399/06/10
Update count:0
Registration date
2020-08-31, 1399/06/10
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
2020-08-21, 1399/05/31
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of a herbal anti acne gel with clindamaycin gel in patients with mild to moderate acne
Public title
preparation and clinical trial Of herbal anti acne gel in comparison with clindamaycin gel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with mild to moderate acne, defined as global acne grading system (GAGS) scale who
patients who have not used topical anti acne drugs in the recent month patients
have not used oral anti acne drugs in past 2 months
Exclusion criteria:
Age
From 15 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
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
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
2020-07-24, 1399/05/03
Ethics committee reference number
IR.AJUMS.REC.1399.368
Health conditions studied
1
Description of health condition studied
acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Total lesion count
Timepoint
Before intervention, 4th and 8th weeks after start of intervention and 4 weeks after end of intervention.
Method of measurement
counting the comedones, papules and pustules number.
2
Description
acne severity index
Timepoint
Before intervention, 4th and 8th weeks after start of intervention and 4 weeks after end of intervention.
Method of measurement
Counting lesions based on Acne Severity Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical use herbal formulation made in ahvaz pharmacy school after washing with antibacterial soap 3 times in day for two months
Category
Treatment - Drugs
2
Description
Control group: topical use Clindamycin 1% Najo after washing with antibacterial soap 3times in day for two months
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
Rayka raya teb co
Full name of responsible person
ali aghaei
Street address
golestan
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 8149
Email
ali.aghaei110@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rayka raya teb co
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
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
61357-15794
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
61357-15794
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
61357-15794
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