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Investigating the Effect of Oral Curcumin on Perineal Pain Severity and Episiotomy Wound Healing Speed in Postpartum Women Undergoing Normal Delivery: A Clinical Trial Study in Selected Centers of Isfahan Province

Protocol summary

Study aim
Determining the Effects of Curcumin (Oral) on Perineal Pain Intensity and Episiotomy Wound Healing Rate in Postpartum Women
Design
Participants (n=59, accounting for a 10% attrition rate, thus n=66 initially) will be randomly allocated, for example, based on odd and even numbers, into two groups (30 participants each): the intervention group (curcumin consumers) and the control group (non-curcumin consumers). The study will be conducted in selected educational hospitals in Isfahan province.
Settings and conduct
Pre-Intervention: Record baseline data (age, height, weight, medical history, delivery status). Baseline Assessment: Measure pain (VAS) and wound status (REEDA) 4 hours post-episiotomy, before intervention. Follow-up: Assess pain (VAS) and wound status (REEDA) on postpartum days 7 and 10 by a trained researcher. Standardization: Ensure consistent episiotomy type, repair, suture, local anesthetic, and analgesics to minimize confounding variables. Intervention Group: Curcumin supplement until postpartum day 10. Control Group: No curcumin. Location: Educational hospitals in Isfahan province.
Participants/Inclusion and exclusion criteria
Gestational age between 37 to 42 full weeks, no sensitivity to turmeric, presence of a single live fetus, normal body mass index, mediolateral episiotomy, women must be breastfeeding and willing to continue breastfeeding, no consumption of specific analgesics, no use of specific medications and no history of chronic systemic diseases.
Intervention groups
Intervention Group: Received curcumin supplementation until day 10 postpartum. Control Group: No curcumin consumption
Main outcome variables
Perineal pain severity, Episiotomy wound healing rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250113064368N3
Registration date: 2026-04-13, 1405/01/24
Registration timing: registered_while_recruiting

Last update: 2026-04-13, 1405/01/24
Update count: 0
Registration date
2026-04-13, 1405/01/24
Registrant information
Name
Mina Jouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 233 4730
Email address
minajouzi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-04, 1405/01/15
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Oral Curcumin on Perineal Pain Severity and Episiotomy Wound Healing Speed in Postpartum Women Undergoing Normal Delivery: A Clinical Trial Study in Selected Centers of Isfahan Province
Public title
Investigating the Effect of Oral Curcumin on Perineal Pain Severity and Episiotomy Wound Healing Speed in Postpartum Women Undergoing Normal Delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 37 to 42 full weeks presence of a single live fetus normal body mass index mediolateral episiotomy women must be breastfeeding and willing to continue breastfeeding
Exclusion criteria:
no sensitivity to curcumin no consumption of specific analgesics no use of specific medications (glucocorticoids, anticoagulants, chemotherapy, immunosuppressants, radiotherapy) no history of chronic systemic diseases (cardiac, renal, pulmonary, coagulation disorders, immunodeficiency, connective tissue disorders, diabetes, anemia, psychiatric illnesses, hemophilia, and malnutrition)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 59
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted through allocation based on the sequential inpatient file numbers. After eligibility confirmation and prior to any intervention, each participant received a unique hospital admission file number. According to a prespecified odd–even allocation rule, participants with even numbers were assigned to the control group, while those with odd numbers were allocated to the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Pre-intervention: Baseline information including age, height, weight, medical history, and delivery status will be recorded.Baseline Assessment: Pain (VAS) and wound status (REEDA) will be measured and recorded 4 hours post-episiotomy and prior to the intervention.Follow-up and Re-assessment: Pain intensity (VAS) and wound status (REEDA) will be assessed by a trained researcher on the seventh and tenth days postpartum.Standardization: All units will have the same type of episiotomy, repair method, suture type, amount of local anesthetic prior to incision, and type of adjunctive analgesics to minimize confounding variables.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Najafabad Branch, Islamic Azad University
Street address
University Boulevard
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2026-04-04, 1405/01/15
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.254

Health conditions studied

1

Description of health condition studied
Episiotomy Wound
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of Perineal Pain and Healing Speed of Episiotomy Wound
Timepoint
Pain (VAS) and Wound Status (REEDA) are measured and recorded 4 hours after episiotomy (before the intervention, on the seventh and tenth day after daily curcumin consumption).
Method of measurement
The Visual Analogue Scale (VAS) tool for assessing pain intensity and the REEDA (Redness, Edema, Echymosis, Discharge, Approximation) tool for assessing wound status.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving curcumin supplements up to day 10 postpartum.
Category
Treatment - Drugs

2

Description
Control group: Without curcumin consumption.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University-Najafabad Branch
Full name of responsible person
Mina Jouzi
Street address
University Boulevard.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2581
Email
minajouzi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mina Jouzi
Street address
University Boulevard.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2581
Email
minajouzi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mina Jouzi
Position
Research Manager
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Boulevard
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2581
Email
minajouzi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mina Jouzi
Position
Research Manager
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Boulevard
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2581
Email
minajouzi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mina Jouzi
Position
Research Manager
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Boulevard.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2581
Email
minajouzi@gmail.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
Due to the preservation of confidentiality, there are no plans for its publication.
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
No - There is not 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
No - There is not a plan to make this available
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