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Protocol summary
This is a double-blinded study.90 patients are enrolled in the study. They were divided into three groups accidentally the herbal formulations and also povidone iodine were used as sitz bath twice daily for a week and participants were visited on the o, 5 and 7 day after delivery. REEDA questionnaire have been used to evaluate wound healing.
This is a double-blinded study.90 patients are enrolled in the study. They were divided into three groups accidentally the herbal formulations and also povidone iodine were used as sitz bath twice daily for a week and participants were visited on the o, 2 and 7 day after delivery. REEDA questionnaire have been used to evaluate wound healing.
This is a double-blinded study.90 patients are enrolled in the study. They were divided into three groups accidentally the herbal formulations and also povidone iodine were used as sitz bath twice daily for a week and participants were visited on the o, 52 and 7 day after delivery. REEDA questionnaire have been used to evaluate wound healing.
این یک مطالعه دو سو کور می باشد.تعداد نود نفر بیمار در این مطالعه شرکت داشته اند و به طور تصادفی به سه گروه مرمکی، کندر و بتادین تقسیم شده اند. هر کدام از داروها دو بار در روز در تشت آب استفاده شده اند و بیماران در روز صفر، پنج و هفت پس از زایمان ویزیت شده اند. از پرسشنامه ریدا برای برسی میزان بهبود زخم استفاده شده است.
این یک مطالعه دو سو کور می باشد.تعداد نود نفر بیمار در این مطالعه شرکت داشته اند و به طور تصادفی به سه گروه مرمکی، کندر و بتادین تقسیم شده اند. هر کدام از داروها دو بار در روز در تشت آب استفاده شده اند و بیماران در روز صفر، دو و هفت پس از زایمان ویزیت شده اند. از پرسشنامه ریدا برای برسی میزان بهبود زخم استفاده شده است.
این یک مطالعه دو سو کور می باشد.تعداد نود نفر بیمار در این مطالعه شرکت داشته اند و به طور تصادفی به سه گروه مرمکی، کندر و بتادین تقسیم شده اند. هر کدام از داروها دو بار در روز در تشت آب استفاده شده اند و بیماران در روز صفر، پنجدو و هفت پس از زایمان ویزیت شده اند. از پرسشنامه ریدا برای برسی میزان بهبود زخم استفاده شده است.
Primary outcomes
#1
The 0, 5 , 7 day after delivery
The 0, 2 , 7 day after delivery
The 0, 52 , 7 day after delivery
روز صفر، پنج و هفت پس از زایمان
روز صفر، دو و هفت پس از زایمان
روز صفر، پنجدو و هفت پس از زایمان
Protocol summary
Study aim
Evaluate the effect of Boswellia spp. and Commiphora Myrrh and comparing them with betadine solution on repair of the episiotomy wound after normal vaginal delivery, with regard to "REEDA" questionnaire.
Design
This is a double-blinded study.90 patients are enrolled in the study. They were divided into three groups accidentally the herbal formulations and also povidone iodine were used as sitz bath twice daily for a week and participants were visited on the o, 2 and 7 day after delivery. REEDA questionnaire have been used to evaluate wound healing.
Settings and conduct
This study for evaluate the effect of Myrrh and Boswellia spp.on episiotomy wound healing and compariing it with betadine solution in Hafez and Zeinabie hospital was done. Formulation A, B and C have been administered in the similar bottles, so patients and researchers were unable to detect. Our nurse colleague in this study delivered formulations to the participants of the study according to the randomized block table. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
Participants/Inclusion and exclusion criteria
Inclusion criteria: NVD with mediolateral episiotomy; parity 1; normal BMI before pregnancy< 25 ; GA 37 to 42 wks; Available for several post-partum visits
Exclusion Criteria: complications immediately after delivery; instrumental delivery; 3º or 4º degree perineal laceration; who have history of medical problems like diabetes mellitus...; Previous history of perineorrhaphy; perineal hematoma; post-delivery fever > 38; smokers; infection of the episiotomy site; prolonged rupture of membranes
Intervention groups
Group intervention 1 received herbal formulation based on Myrrh, group intervention 2 herbal formulation based on Boswellia and control group Betadine solution.
Main outcome variables
Wound healing
General information
Reason for update
Recording errors
Acronym
IRCT registration information
IRCT registration number:IRCT20140525017827N5
Registration date:2019-07-28, 1398/05/06
Registration timing:prospective
Last update:2019-12-23, 1398/10/02
Update count:3
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-29, 1398/05/07
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Commiphora Myrrh, Boswellia Spp. And Betadine Solution For Repair of Episiotomy After Normal Vaginal Delivery
Public title
Comparison Between Myrrh, Boswellia And Betadine For Repair of Episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Who have normal vaginal delivery with mediolateral episiotomy.
parity 1
Normal body mass index (BMI) before pregnancy (less than 25).
Gestational age 37 to 42 weeks
Available for several post partum visits
Exclusion criteria:
Mothers who have complications immediately after devilry
instrumental delivery
3º or 4º degree perineal laceration
who have history of medical problems like diabetes mellitus, hypertention, anemia, Rheumatology disease...
Previous history of perineorrhaphy
perineal hematoma
post delivery fever upper than 38 degree of centigrade
smokers
infection of the episiotomy site
prolonged rupture of membranes
Age
From 18 years old to 41 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Formulation A, B and C have been administered in the similar bottles, are made by the pharmacists with the same appearance and characteristics and will be given to our colleague drug distributor in the form of A or B or C. The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software.
1 (A), 2 (B), 3 (B), 4 (B), 5 (A),…….
Any eligible patient will be given a 1 to 90 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B or C drug. The drug distributor doesn’t have a role in the treatment plan and data analysis. The patients, researcher, data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Formulation A, B and C have been administered in the similar bottles, so patients and researchers were unable to detect which one was Myrrh, Boswelia and betadine. Our nurse colleague in this study in Hafez and Zeinabie hospitals delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.SUMS.MED.REC.1398.001
Health conditions studied
1
Description of health condition studied
Episiotomy wound healing
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
wound healing
Timepoint
The 0, 2 , 7 day after delivery
Method of measurement
visiting the paients and filling " REEDA" questionnaire by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A will receive herbal formulation based on Myrrh, Hydro alcoholic extract of Myrrh resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice a day for a week.
Category
Treatment - Drugs
2
Description
Intervention group: Group B will receive herbal formulation based on Boswellia, Hydro alcoholic extract of Boswellia resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice daily for a week.
Category
Treatment - Drugs
3
Description
Control group: Patients in group C will use Betadine solution, 15 cc in 5 liter of water for 10 minutes, twice daily for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghehi Hospital affiliated to Shiraz University of Medical Science
Full name of responsible person
Marym Aghdaki
Street address
Shahid Faghehi Hospital, Zand blvd
City
Shiraz
Province
Fars
Postal code
71848-37786
Phone
+98 71 3233 2365
Email
maryam.aghdaki@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University Of medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Marya Aghdaki
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
maryam.aghdaki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
nsasadi2002@yahoo.ca
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
nasadi2012@yahoo.ca
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
En IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2019 Ethic form: 2019
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document