Determining the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon
Design
A three-blind randomized controlled clinical trial will be conducted on 140 first-time pregnant women who are eligible to participate in the study and refer to the health centers of Zahedan city, who will be selected as available, then the research units will be randomly assigned to two intervention groups. (Ointment) and placebo will be placed. The sequence of random allocation of people to the studied groups will be done by Allocation Concealment method.
Settings and conduct
This study will be conducted in the field of herbal medicine with the aim of determining the effect of Beneh ointment on the prevention of pregnancy stretch marks in first-time pregnant women. Each of the intervention and control groups has 70 samples.
Participants/Inclusion and exclusion criteria
1) Informed consent to participate in the study 2) Age between 20 and 35 years 3) Being pregnant for the first time 4) Pregnancy age between 24 and 26 weeks 4) Singleton pregnancy 6) Not using corticosteroids and any type of topical or systemic corticosteroids 7) Not using any kind of cream or oil in the abdominal area 8). The mother does not suffer from obstetric problems such as: hydramnios, provia 9). Body mass index should be between 18.50 and 30. 10). Mother's absence of Cushing's disease11). The absence of the mother from Marfan's disease 12). The absence of the mother from anorexia nervosa 13). The absence of the mother from chronic liver disease 14). The absence of any type of lesion or wound at the intervention site 15). Not having diabetes 16). Absence of allergy to Beneh ointment or no history of allergy to Beneh fruit 17). Mother's absence of previous stretch marks in the abdominal area.
Intervention groups
pistacia atlantica oil
Main outcome variables
Stretch, Erythema,Itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230720058860N1
Registration date:2023-11-27, 1402/09/06
Registration timing:registered_while_recruiting
Last update:2023-11-27, 1402/09/06
Update count:0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Mansureh Tork Hesari tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 044 0914
Email address
torkhesarim4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon
Public title
A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Age between 20 and 35 years
Being pregnant for the first time
Pregnancy age between 22 and 26 weeks
Singleton pregnancy
Not using corticosteroids and any type of topical or systemic corticosteroids
Not using any kind of cream or oil in the abdominal area
Not suffering from hydramnios
Body mass index at the beginning of pregnancy or in the last trimester of the first trimester should be between 18.50 and 30
Mother's absence of Cushing's disease
The absence of the mother from Marfan's disease
The absence of the mother from anorexia nervosa
The absence of the mother from chronic liver disease
The absence of any type of lesion or wound at the intervention site
Not having diabetes
No allergy to Beneh ointment or no history of allergy to Beneh fruit
Exclusion criteria:
Reluctance to continue cooperation with the research unit
Occurrence of hydramnios.
Use of corticosteroid drugs (local and systematic).
Use of any type of cream or oil on the abdominal area during the study
Non-consecutive days during the study
Rupture of fetal membranes, childbirth or termination of pregnancy for any reason
Having gestational diabetes during the study
Age
From 20 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation Concealment: envelopes will be prepared as many as the sample size (140). Half of the envelopes are for the intervention group and the other half for the control group. Inside the sealed envelopes, the type of group (intervention or control) will be specified on a sheet. Then the envelopes are closed. When the research units enter the research environment, an envelope will be randomly selected for them and the type of group to which the sample will be assigned will be revealed
Blinding (investigator's opinion)
Triple blinded
Blinding description
When preparing medicine and placebo, the pharmacist gives a code of one or two to their cans, and the code will remain hidden for the researcher, research unit and data analyst until the end of the analysis.
Placebo
Used
Assignment
Parallel
Other design features
On the first day of visit, some ointment is used on the inside of the forearm of the research unit, if no sensitivity occurs after 15 minutes, the severity of stretch marks, erythema and itching in the abdominal area, with the help of Davy's checklists and Kamini's checklists And it is checked.Then he explains how to use Beneh Ointment to the research unit and asks him to use 3 cm of 10% Oserin-based Beneh Ointment on the abdomen every day and emphasizes that during and after using Beneh Ointment on the abdomen don't massage and perform this procedure for 8 weeks in a row.Every 4 weeks, the research units must visit the research site and be evaluated by the researcher. After 8 consecutive weeks of intervention, immediately after the end of the intervention, the research units will return to the research environment to be examined again by the researcher.On the day after the end of the intervention, the Davi, Atwal and Kamini checklists are completed again by the researcher. The study and follow-up process in the control group (placebo) is the same as the intervention group, but instead of the placebo ointment (Oserin) that is in the cans It is similar to a can of ointment, they will use it.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
No. Azadi Ave., Kharazmi Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.092
Health conditions studied
1
Description of health condition studied
stretch marks
ICD-10 code
O99.7
ICD-10 code description
Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium.
Primary outcomes
1
Description
Itching
Timepoint
First day of visit and the day after the end of the intervention
Method of measurement
Kamini checklist
2
Description
Erythema
Timepoint
First day of visit and the day after the end of the intervention
Method of measurement
Otwal checklist
3
Description
Striae
Timepoint
First day of visit and the day after the end of the intervention
Method of measurement
Davey checklist
Secondary outcomes
1
Description
Complication of the intervention
Timepoint
the day after the end of the intervention
Method of measurement
Copmlications checklist
2
Description
Satisfaction with the intervention
Timepoint
the day after the end of the intervention
Method of measurement
Intervention satisfaction questionnare
Intervention groups
1
Description
Intervention group: The intervention process in the intervention group is such that on the first day of the research units' visit to the research environment, the researcher uses some ointment on the skin of the inner forearm of the research unit, if after 15 minutes there is no itching, burning, Inflammation and discoloration did not occur (lack of drug sensitivity), the severity of striae, erythema and itching in the abdominal area, with the help of medication checklists (for this purpose, first, with the help of a surgical marker on the abdomen of the research unit, two perpendicular lines If their point of intersection is on the navel, he divides it into four equal parts and scores each part according to the checklist, then adds the total scores of the four parts together and determines the severity of striae according to the checklist, and completes the Kamini and Etowal checklists. Then he explains how to use Beneh ointment to the research unit and asks him to use 3 cm of 10% Oserin-based Beneh ointment on the stomach every day and emphasizes that during and after using the ointment Do not massage the abdomen and perform this procedure for 8 consecutive weeks. The researcher will follow up the use of the ointment once a week by the research units (both in the placebo group and in the intervention group) by telephone. . and asks them to fill in the checklist of the study process. In addition to this, the researcher forms a group in Eta, Yes or Rubika so that all the research units are placed in that group after entering the study, and they are reminded to use the drug daily. and asks the research units to visit the research site every 4 weeks and be evaluated by the researcher. After 8 consecutive weeks when the intervention was carried out, immediately on the day after the end of the intervention, the research units will return to the research environment to be re-evaluated by the researcher. The researcher should be examined. It should be noted that on the day after the end of the intervention, Davy, Atwal and Kamini checklists are completed again by the researcher. In addition to the examination checklists, questionnaires.
Category
Treatment - Drugs
2
Description
Control group: The study and follow-up process in the control group (placebo) is the same as the intervention group, but instead of Beneh ointment, they will use a placebo (Oserin) which is in the same cans as Beneh ointment. At the end of the intervention, the study process checklist will be received from the research unit.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Abolfazl Zahedan Health Center
Full name of responsible person
Dr. Hosein Poor karami
Street address
No. 12, Dareh Pange Sheer Ave.,Abozar Blvd., Zahedan Town
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817784381
Phone
+98 54 3351 3902
Fax
Email
TorkHesari4001@mums.ac.ir
Web page address
http://balad.ir
2
Recruitment center
Name of recruitment center
Khadamat jame salamat emam sajad
Full name of responsible person
Dr.Sharzad Miri
Street address
No. 10, Emam Khomeini 19 Ave., Zahedan Town.
City
زاهدان
Province
Sistan-va-Balouchestan
Postal code
9817784381
Phone
+98 54 3322 9684
Fax
Email
TorkHesari4001@mums.ac.ir
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research assistant of Mashhad University of Medical Sciences: Talaat Hkadiv Zadeh
Street address
No. Azadi Ave., Kharazmi Blv., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3189 2105
Email
TorkHesari4001@mums.ac.ir
Web page address
http://www.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Kobra Mirzaei
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. Azadi Ave., Kharazmi Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9117712390
Phone
+98 938 420 2290
Email
Mirzakhanik@mums.ac.ir
Web page address
http://mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Kobra Mirza Khani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. Azadi Ave., Shahib Kharazmi Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2105
Fax
Email
Mirzakhanik@mums.ac.ir
Web page address
http://www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Kobra Mirza Khani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. Azadi Ave., Kharazmi Blv., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
Mirzakhanik@mums.ac.ir
Web page address
http://www.mums.ac.ir
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
A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon
When the data will become available and for how long
Available in the journal after publication
To whom data/document is available
All people who are interested in the article
Under which criteria data/document could be used
Promoting the method of preventing pregnancy stretch marks
From where data/document is obtainable
They send email to the corresponding author
What processes are involved for a request to access data/document
Explain the reasons for requesting the article in the email