The effect of Anahil 500 (bromelain 500) and vitamin C on episiotomy wound healing in primiparous women.
Design
In a randomized clinical trial with the parallel control group, double-blind; Phase 2-3, on 240 patients; randomization is performed by using block randomization
Settings and conduct
In this double-blind clinical trial parallel study, 140 patients who are candidates for normal vaginal delivery in Fatemieh Hospital in Hamadan will be included in the study. The researcher who measures and records the consequences and the patients are unaware of the type of intervention performed, so the study is conducted in a double-blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 40 years; Gestational age between 37 to 42 weeks; single pregnancy; cephalic presentation
Normal vaginal delivery; newborn Weight between 2500 to 4000 grams; Medio-lateral episiotomy with 4-3 cm length; Education level at least the fifth grade,
body mass index: 19.8-26 kg/m2; Cervical dilation 3-5 cm
Exclusion criteria: Diseases affecting wound healing; Smoking and drug abuse
Consumption of drugs affecting wound healing (glucocorticoids, anti-coagulative, immune system suppressants, antibiotics, or chemotherapy agents); abortion; premature rupture of membranes; having symptoms indicative of infection; Anemia; abnormal first, second, or third delivery stage
dead baby.
Intervention groups
bromelain 500mg (one tablet) 2 hours after delivery three times a day along with oral vitamin C 100mg one tablet and in the other three groups, bromelain tablets; Vitamin C or placebo alone for seven days after delivery.
Main outcome variables
Wound healing and pain intensity after delivery using visual scale pain and Rida scale up to 7 days after delivery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N25
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Anahil 500 (bromelain 500) and vitamin C on episiotomy wound healing in primiparous women
Public title
The effect of Anahil 500 (bromelain 500) and vitamin C on episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 40 years
Gestational age between 37 to 42 weeks
single pregnancy
cephalic presentation
Normal vaginal delivery
newborn Weight between 2500 to 4000 grams
Medio-lateral episiotomy with 4-3 cm lengt
Education level at least the fifth grade,
body mass index: 19.8-26 kg/m2
Cervical dilation 3-5 cm
Exclusion criteria:
Diseases affecting wound healing
Smoking and drug abuse
Consumption of drugs affecting wound healing (glucocorticoids, anti-coagulatives, immune system suppressants, antibiotics or chemotherapy agents)
abortion
premature rupture of membranes
having symptoms indicative of infection
Anemia
abnormal first, second or third delivery stage
dead baby
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used to implement random assignment. In this way, 140 consecutive (from 1 to 1400) will be written individually on paper and will be placed in a container. Then, each of the participants in the trial is asked to randomly select one of these 140 numbers in the container containing the numbers. Individuals who have selected numbers from 1 to 35 will be assigned to group A ("Intervention group 1") and those who have chosen numbers 36 to 70 to group B ("Intervention group 2") those who have selected numbers 71 to 106 to group C ("Intervention group 3") and those who have selected numbers 107 to 1400 to group d (control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will be unaware of the type of intervention. The physician examining the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-07-23, 1401/05/01
Ethics committee reference number
IR.UMSHA.REC.1401.411
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
090
ICD-10 code description
Complications of the puerperium, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
2 hrs after delivery, 24 hrs after delivery, 1 hr after consumption of initial dose
Method of measurement
VAS scale
2
Description
wound healing
Timepoint
3th, 7th, and 14th day after deliver
Method of measurement
REEDA scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day along with oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery.
Category
Treatment - Drugs
2
Description
Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day for seven days.
Category
Treatment - Drugs
3
Description
Intervention group: oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery.
Category
Treatment - Drugs
4
Description
Control group: Placebo, one tablet, from 2 hrs after delivery, three times daily for seven days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Shahla Nasrolahi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 912 915 6058
Email
Dr-nasrolahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shahla Nasrolahi
Position
Associate Professor of Perinatology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
fatemeh salmani andabili
Position
Resident Gynecology and Obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Salmani.fatemeh5@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
fatemeh salmani andabili
Position
Hamadan
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Salmani.fatemeh5@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD