Accesment of the effect of gel containing Moringa Oleifera leaf powder on wound healing of breast cosmetic surgeries
Design
Phase 1 clinical trials are performed on 30 patients. Randomization uses the rand function of Excel software. According to the instructions on the random envelopes, the gels are labeled with two different colors, neither the researchers nor the participants know which breast received which gel.
Settings and conduct
First, water-alcoholic extract is taken from the dry powder of Moringa in suitable laboratory conditions and then it is concentrated. Then, the base gel is made using chitosan polymer powder and 3% concentration of gels is made using the concentrated extract of Moringa Olifra plant. 30 female patients are selected selectively. The duration of treatment is twice a day for 14 days and patients follow up for up to 3 months to control the wound healing process and scar formation. Then, at the end of the second week and the third month, the patients were evaluated for wound healing process and Vancouver criteria by two clinical assistants. Then it was analyzed using data collection form. The participant, The researcher, the analyst dont know which side received which gel
Participants/Inclusion and exclusion criteria
patients referred for aesthetic breast surgery
Inclusion Critera
- Age 18 to 70 years
- Gaining informed consent
- Exclusion Criteria:
-Chemotherapy
- Drug abuse
- Systemic diseases
- Receiving corticosteroid drugs
-Drug addiction
-Cancer
- Taking any hormonal medication
-Smoking
Intervention groups
The lateral side of a breast is rubbed with gel Moringa plant extract
The medial side of the same breast that has not been rubbed anything
The lateral side of the breast is rubbed against the placebo gel
The medial side of the same breast that has not been rubbed anything
Main outcome variables
Flexibility
Height
Pigments
Vascularity
General information
Reason for update
Acronym
Moringa Oleifera - wound healing MO-WH
IRCT registration information
IRCT registration number:IRCT20211206053294N1
Registration date:2021-12-25, 1400/10/04
Registration timing:registered_while_recruiting
Last update:2021-12-25, 1400/10/04
Update count:0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Shirin Haji Mazdarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
sh.mazdarani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chitosan gel containing Moringa Olifra leaf powder on surgical wound healing Breast cosmetic surgery
Public title
The effect of gel containing Moringa Olifra on surgical wound healing Breast cosmetic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 70
Gain conscious satisfaction
Female patients referred for cosmetic breast surgery including prosthesis and reduction mammoplasty
Exclusion criteria:
Chemothrapy
Drug abuse
Systemic diseases
Get corticosteroids medication
Drug adiction
Cancer
Take any hormonal medication
Smoking
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient in the study knows that if he receives two different jellies on the right and left side of the breast, their effect will be compared, but he does not know which side contains the Moringa plant and which side he has received
Placebo.
The researcher does not know which Moringa wound and which placebo wound he received when scoring the wounds.
The analyst is unaware of the allocation of wounds to the group receiving Moringa gel and the group receiving placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch Ethics Committee of School of Medicine- Shahid Beheshti University of Medical Scieence
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1398.1004
Health conditions studied
1
Description of health condition studied
Wound healing
ICD-10 code
T81.31
ICD-10 code description
Disruption of external operation (surgical) wound, not elsewhere classified
Primary outcomes
1
Description
Vascularity
Timepoint
3 month
Method of measurement
Visual Analogus Scale
2
Description
Pigmentation
Timepoint
3 Month
Method of measurement
Visual Analogus Scale
3
Description
Pliability
Timepoint
3 Month
Method of measurement
Touch
4
Description
Height
Timepoint
3 Month
Method of measurement
Ruler
Secondary outcomes
empty
Intervention groups
1
Description
The wound intervention group received chitosan-based gel containing 3% Moringa Olifera leaf powder extract, made in a traditional medicine laboratory, 24 hours after surgery, twice a day for two weeks
Category
Treatment - Drugs
2
Description
Control group: The wound intervention group received chitosan-based gel without extract of 3% Moringa Olifera leaf powder, made in a traditional medicine laboratory, 24 hours after the operation, twice a day for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Panzdah-e Khordad Hospital
Full name of responsible person
Shirin Hajimazdarani
Street address
Azodi street- Karimkhan Street
City
Teheran
Province
Tehran
Postal code
1598764514
Phone
+98 21 8894 3434
Fax
+98 21 8890 9193
Email
shekayat@sbmu.ac.ir
Web page address
https://pkmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Haji Mazdarani
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Marzdaran blvd- Motahari street-corner of Shabnam ally- number 17- unit 7
City
Tehran
Province
Tehran
Postal code
1464715518
Phone
+98 21 8824 7748
Email
sh.mazdarani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Haji Mazdarani
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Marzdaran bluv- Motahari street- Corner of Shabnam ally -number 17- unit 7
City
Tehran
Province
Tehran
Postal code
1464715518
Phone
+98 21 8824 7748
Email
sh.mazdarani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Haji Mazdarani
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Marzdaran bluv- Motahari street- Corner of Shabnam ally -number 17- unit 7
City
Teheran
Province
Tehran
Postal code
14647115518
Phone
+98 21 8824 7748
Email
sh.mazdarani@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
تمام اطلاعات در قالب یک مقاله شش ماه پس از اتمام کار در اختیار متقاضیان قرار خواهد گرفت
When the data will become available and for how long
Access started from September 2022
To whom data/document is available
All data will be made available to researchers working in the institutions of scientific and academic universities
Under which criteria data/document could be used
students
From where data/document is obtainable
Applicants can email Shirin Haji Mazdarani to sh.mazdarani@yahoo.com or 09126063272
What processes are involved for a request to access data/document
Participants can send all their questions via email. All information will be provided to respondents in the form of a report via email within one month