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Investigating the effect of Astragalus fasciculifolius and Phenytoin Cream on pain and episiotomy wound healing in primiparous women

Protocol summary

Study aim
Comparison of the effect of Astragalus fasciculifolius cream and phenytoin cream on pain intensity and healing of episiotomy wound in primiparous women
Design
A randomized triple blind, parallel and phase 3 clinical trial study on 120 primiparous women with use of block permutation randomization method, they divided into 2 intervention groups and a control group with a ratio of 1:1:1.
Settings and conduct
120 volunteer mothers referring to Taleghani Arak maternity hospital with inclusion criteria are randomly divided into three groups (two intervention groups and one control group). Vaseline-based creams prepared by a traditional medicine pharmacist will be filled in similar white tubes (with a capacity of 60 cc) with the names A, B, and C. Researcher, participant, outcome evaluator, and results analyzer (data is coded) and the data safety and monitoring committee will not know the contents of the tubes until the end of the investigation and announcement of the results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal pregnancy and delivery, age 15 to 45 years and body mass index 18 to 30; Exclusion criteria: Suffering from diseases that interfere with wound healing or taking drugs that affect wound healing
Intervention groups
Intervention group 1: Astragalus fasciculifolius creams 10% Intervention group 2: Phenytoin cream 1% Control group: placebo cream All three groups are used their cream in the amount of 5 cc, every 8 hours for 10 days from the first day after delivery, along with routine treatment .
Main outcome variables
Episiotomy wound pain severity and recovery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220816055724N3
Registration date: 2022-12-17, 1401/09/26
Registration timing: registered_while_recruiting

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Fereshteh Farzanazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
farzanazar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Astragalus fasciculifolius and Phenytoin Cream on pain and episiotomy wound healing in primiparous women
Public title
The Effect of Astragalus fasciculifolius and Phenytoin Cream on pain and episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal pregnancy and delivery primiparous Age between 15-45 Having at least reading and writing literacy Body mass index (after delivery) between 18.5-30 kilograms per square meter
Exclusion criteria:
Gestational age below 37 or above 42 weeks Multiple pregnancy Fetus Malpresentation Suffering from diseases that interfere with wound healing such as: anemia, infection and perineum wounds, diabetes, High blood pressure, diseases of skin, heart, kidney, lung , coagulation disorder, immunodeficiency, hemophilia, disorder of connective tissue, depression, malnutrition, mental illnesses, cancer) Using drugs effective on wound healing such as: anticoagulants, antidepressants, antiepileptics), glucocorticoids, immune system suppressors, antibiotics, narcotics and psychotropic drugs, chemotherapy Rupture of Amionitic membran more than 18 hours Instrumental vaginal delivery or non-medial or lateral episiotomy incision Non spontaneous removal of the placenta History of previous injury or surgery or visible lesions in the perineum such as: genital warts, hemorrhoids Alcohol drinking or smoking Persistent constipation (according to the mother statement )
Age
From 15 years old to 45 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: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study with a sample size of 120 people, to balance the number of samples allocated in each group, the participants will be randomly placed into three groups of 40 people (two intervention groups and one control group) by using the block permutation randomization. We need 20 blocks of 6 for 120 people. We select these blocks using random allocation software, which is capable of generating a random sequence using the blocking method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Astragalus fasciculifolius plant cream and placebo cream based on vaseline, prepared by a traditional medicine pharmacist and phenytoin cream prepared by Amin Pharmaceutical Company , at the traditional medicine research center, will be filled in similar white tubes ( with a capacity of 60 cc) as named as A, B and C and will be available to the researcher to conduct research. The researcher, the participant, the outcome assessor , the results analyzer and the data safety and monitoring committee will not know the contents of the tubes until the end of the review and announcing the results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University Of Medical Science, Almalhoda Avenue, Arak, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.ARAKMU.REC.1401.097

Health conditions studied

1

Description of health condition studied
Pain severity
ICD-10 code
G89.18
ICD-10 code description
Other acute post procedural pain

2

Description of health condition studied
Wound healing
ICD-10 code
O90.1
ICD-10 code description
Disruption of peritoneal obstetric wound

Primary outcomes

1

Description
Pain
Timepoint
Days1, 5 and 10 after delivery
Method of measurement
Visual analog scale (VAS)

2

Description
Episiotomy wound healing
Timepoint
Days1, 5 and 10 after delivery
Method of measurement
Reeda Questionnaire

Secondary outcomes

1

Description
Drug side effect
Timepoint
Days 5 and 10 after delivery
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group 1; Astragalus fasciculifolius Cream 10%: This herbal cream (Astragalus fasciculifolius plant), based on Vaseline and 10% active substance concentration, will be made by a traditional medicine doctor in a traditional medicine laboratory. This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment.
Category
Treatment - Drugs

2

Description
Intervention group 2; Phenytoin Cream 1%: Phenytoin cream 1% is produced by Amin Pharmaceutical Company. It is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups). This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment.
Category
Treatment - Drugs

3

Description
Control group: Placebo Cream: The Vaseline cream is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups).This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Maternity Hospital
Full name of responsible person
Dr Abolfazl Safari
Street address
Talegany hospital,Emam khomini Avenue, Arak, Iran
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3275 6063
Fax
Email
It-taleghani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Arak University of Medical Sciences Complex, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Fax
+98 86 3383 8319
Email
salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Fereshteh Farzanazar
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Mojtame Paiambarazam, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Fax
+98 86 3417 3521
Email
dr.faezanazar@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mojtame Paiambarazam, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
dr.salehi@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fereshteh Farzanazar
Position
Facuty Member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Mojtame Paimbarazam, Sardasht , Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
dr.farzanazar@arakmu.ac.ir

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
There is no further information
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data is shareable
When the data will become available and for how long
After the end of research
To whom data/document is available
Academic institutions and journals
Under which criteria data/document could be used
Obtaining information about the method and general results
From where data/document is obtainable
Arak University Of Medical Science
What processes are involved for a request to access data/document
Written request and during two months
Comments
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