Examining the effects of Anaheal Plus supplement on the healing of acne scars, Examining the change in the surface of acne spots with Anaheal Plus, Examining the change in inflammation caused by acne with Anaheal Plus, Examining the change in the number of lesions caused by acne scars with Anaheal Plus
Design
Clinical trial with control group, based on community and practical, on 50 patients
Settings and conduct
The method of conducting this study will be a clinical trial and the participating patients will be selected from the patients of the clinics and hospitals of Tehran Islamic Azad University.
After receiving Anaheal Plus supplement by the first group and receiving placebo by the second group, both groups will be examined at the end of the study in terms of changes in the level and intensity of the spots caused by acne, as well as the number of acne lesions and the degree of inflammation and redness of the lesions.
The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process.
Participants/Inclusion and exclusion criteria
Patients over 18 years old with acne scars
Intervention groups
50 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and half of these people, who will be placed in the intervention group by using a random number table, will receive A H A exfoliator and Anaheal Plus supplement for one month.
Considered variables will be checked one month after the start of the treatment. The rest of the studied patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo instead of Anaheal plus.
Main outcome variables
Number of lesions, Area of the scar, Inflammation, Redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N17
Registration date:2023-08-22, 1402/05/31
Registration timing:prospective
Last update:2023-08-22, 1402/05/31
Update count:1
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of Anaheal plus supplement on inflammation and scarring caused by acne
Public title
Anaheal plus effect on acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acne scarring
Age range over 18 years
Exclusion criteria:
Allergy to pineapple, curcuma, celery, carrot and fennel
Pregnancy
Lactation
Renal failure (GFR<30)
liver failure (Child pugh B,C)
Hemophillia
Using two antiplatelet drug
Using one anti platelet and one anti coagulant drug
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study, each patient is assigned a code (1 or 2) using Rand number. Conventionally, the patient who received code one will receive drug and the patient who received code two will receive placebo. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be Single blinded in such a way that the participants will not be aware of the contents of the medicine package they receive. A code will be assigned to each patient using a Rand number. Patients whose code is 1 will receive the drug, and patients who are assigned a code of 2 will receive a placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Department of Pharmaceutical Sciences,Tehran Islamic Azad University of Medical
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
تهران
Province
Tehran
Postal code
۱۹۳۹۵۶۴۶۶
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.IAU.PS.REC.1402.100
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
The number of lesions caused by acne scars
Timepoint
30 days
Method of measurement
Observational
2
Description
Area of scar caused by acne
Timepoint
30 days
Method of measurement
Measure with a ruler
3
Description
Inflammation
Timepoint
30 days
Method of measurement
According to dermatologist opinion
4
Description
Redness
Timepoint
30 days
Method of measurement
According to dermatologist opinion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and receive A H A exfoliator once a day on the areas which have acne scars and also they will consume Anaheal Plus supplement which contains bromelain and curcumin and is produced by Salamat parmoon amin pharmaceutical Co. two times a day (One in the morning and one in the evening) for one month. Considered variables will be checked one month after the start of the treatment.
Category
Treatment - Drugs
2
Description
Control group:25 patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo capsule which is produced by Salamat parmoon amin pharmaceutical Co. twice a day for one month instead of Anaheal plus.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu ali hospitol
Full name of responsible person
Saba Shojaan
Street address
Damavand Street - not reaching Imam Hossein Square - Bu Ali Hospital
City
تهران
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
بیان منوچهری
Street address
West Nafisi, Baradaran Sarafha Ave, Saadat abad Ave.
City
تهران
Province
Tehran
Postal code
1998863174
Phone
+98 21 8869 1099
Email
info@spameda.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal street, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0056
Email
Shiehmorteza@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yakhchal Ave, Dr Shariati
City
Tehran
Province
Tehran
Postal code
۱۹۱۶۸۹۳۸۱۳
Phone
+98 21 2264 0056
Email
Shiehmorteza@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saba Shojaan
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal Ave, Dr Shariati
City
تهران
Province
Tehran
Postal code
1918943935
Phone
+98 21 2264 0056
Email
sabashojaan@yahoo.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
Data are collected in the form of a questionnaire
When the data will become available and for how long
After the intervention
To whom data/document is available
Qualified persons
Under which criteria data/document could be used
Used for scientific advancement in the field under study
From where data/document is obtainable
Clinical office of Islamic Azad University,Medical science of Tehran, Faculty of pharmacy
What processes are involved for a request to access data/document
Request in writing by going through legal procedures