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IRCT20260603069629N1 IRCT 2026-06-23 Gonabad University of Medical Sciences Effect of Jujube Fruit Lotion on Pain intensity and Episiotomy Wound Healing “Effect of Jujube Fruit Lotion on Pain intensity and Episiotomy Wound Healing in Postpartum Women at Allameh Behlol Gonabadi and Hazrat Abolfazl Hospitals, Gonabad and Kashmar, 2025–2026: A Triple-Blind Randomized Clinical Trial” 2026-07-10 anticipated 84 Complete https://irct.ir/trial/90778 observational Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random allocation sequence for assigning participants to the intervention and control groups will be generated by an independent statistician (data analyst) using permuted blocks of four. Allocation codes will be placed in sequentially numbered, opaque, sealed envelopes and will be opened by the researcher only at the time of participant enrollment. Therefore, the researcher will remain unaware of the assigned group until the moment of allocation, ensuring allocation concealment, Blinding description: This study is designed as a triple-blind randomized controlled trial. Participants, the intervention researcher, the outcome assessor, and the statistical analyst will all be blinded to the type of intervention. The lotions (containing Ziziphus jujuba fruit extract and placebo) were prepared to be identical in color, scent, consistency, and packaging, and will be coded uniquely. Data will be entered into the statistical software in a coded format, and the codes will remain confidential until the end of the analysis. The intervention group will receive standard hospital care plus the Ziziphus jujuba fruit lotion. The control group will receive standard hospital care and the base lotion (placebo). The placebo consists of a base lotion without the Ziziphus jujuba extract, which has been standardized to match the appearance of the active lotion. 3 Condition 1: Pain intensity and Episiotomy Wound Healing. Condition 2: Pain intensity and Episiotomy Wound Healing. Intervention 1: Intervention group:Participants allocated to the intervention group will receive routine postpartum care in addition to a topical lotion containing 1% hydroalcoholic extract of jujube fruit (Ziziphus jujuba Mill.). The extract, with 100% purity, will be obtained from the Giah Kala Herbal Refinery. The lotion will be formulated using a standard lotion base and packaged in 25-mL dark-colored bottles.Participants will be instructed to apply approximately 0.5 mL of the 1% jujube lotion as a thin layer over the episiotomy wound twice daily (morning and evening) for 10 consecutive days following childbirth, after cleansing and drying the perineal area. A skin sensitivity test will be performed before initiating the intervention to ensure the absence of allergic reactions. Standardized instructions regarding product application will be provided, and daily reminder messages will be sent to enhance adherence to the intervention protocol. Intervention 2: Control group:Participants allocated to the control group will receive routine postpartum care in addition to a placebo lotion. The placebo will consist of the same lotion base used in the intervention group but without the jujube extract and will be identical in appearance, odor, consistency, packaging, and storage conditions to ensure blinding.Participants will be instructed to apply approximately 0.5 mL of the placebo lotion as a thin layer over the episiotomy wound twice daily (morning and evening) for 10 consecutive days following childbirth, after cleansing and drying the perineal area. The application procedure, duration of use, participant education, and follow-up schedule will be identical to those of the intervention group. Yes - There is a plan to make this available What will be shared: The complete clinical trial dataset, including all variables related to pain intensity and episiotomy wound healing in both the intervention and control groups. All direct and indirect personal identifiers will be removed, and the data will be fully de-identified to protect participants’ privacy. The codebook and variable guide, including definitions of all variables, measurement scales, and coding instructions to facilitate reproducibility of the analyses. The study protocol and data collection instruments, including the final approved protocol, questionnaires, and checklists used to assess wound healing and pain intensity. The statistical analysis files (syntax/scripts), including the codes used in statistical software for data cleaning, management, and analysis, allowing other researchers to reproduce the results. When: Access to the study data and documentation will be granted starting 6 months post-publication To whom: Data and documentation will be available upon request to qualified researchers and institutions Conditions: Research Purpose: Data must be used strictly for non-commercial, ethical scientific research. Security & Privacy: Users must not attempt to re-identify participants or transfer the data to third parties. Acknowledgment: Any publication or output resulting from these data must formally cite the original study and its investigators. Compliance: The request must include a defined analysis plan and confirmation of ethical alignment with the study’s original scope. Where to obtain: The Principal Investigator is responsible for reviewing and responding to all scientific requests. Applicants are required to submit their formal request, including the research project title and a brief description of the study’s objectives, to the following email address: Email: akbari.s.stu@gmu.ac.ir Subject Line: Data Request: Effect of Jujube Lotion on Episiotomy Healing 2. Secondary Contact: Clinical Research Development Office If you do not receive a response within 15 working days, you may forward your request to the Clinical Research Development Office at Gonabad University of Medical Sciences: Mailing Address: Clinical Research Development Office, Vice-Chancellery for Research and Technology, Gonabad University of Medical Sciences, Gonabad, Iran. Phone: +98 51 5722 3028 How to obtain: Applicants are required to submit a formal written request to the Principal Investigator via email, including their full name, institutional affiliation, contact information, the specific study title, and a brief description of the intended purpose of the requested data or documentation. All requests will be reviewed by the research team to ensure alignment with the study’s objectives and ethical requirements. If necessary, the applicant may be requested to provide supplementary information, such as a detailed analysis plan or proof of institutional ethical approval. Upon final approval, the specific terms of data usage will be communicated, and the documents or de-identified data files will be shared via secure channels. Regarding the timeline, the initial review process typically takes 5–7 working days. If additional clarification is required, further communication may take up to 5 working days, and the final preparation and release of the materials usually require 10–15 working days following final approval. Consequently, the entire process is estimated to be completed within 2 to 4 weeks, depending on the completeness of the initial request and the scope of the required review. Comments:
public Akbari Sajede
Asian Roadside
Gonabad Iran (Islamic Republic of) 969169996 +98 51 5722 3028 akbari.s.stu@gmu.ac.ir Gonabad University of Medical Sciences scientific Sajede Akbari
Asian Highway roadside
Gonabad Iran (Islamic Republic of) 9671967557 +98 51 5523 8562 akbari.s.stu@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women in their first or second childbirth Maternal age between 18 and 45 years Gestational age between 37 and 42 completed weeks Maternal BMI in the normal to overweight range (18.5–29.9) Undergoing mediolateral episiotomy during normal vaginal delivery Providing informed consent to participate in the study Delivering a live singleton neonate with a normal birth weight (2500–4000 g) Hospital stay of less than 24 hours 18 years 45 years Female History of perineal skin diseases Allergy to jujube or topical herbal products Presence of active genital infection Systemic diseases affecting wound healing Use of corticosteroid medications Use of nonsteroidal anti-inflammatory drugs above routine doses Use of immunosuppressive medications Occurrence of a stressful event or major incident during the study period Use of anticoagulant medicationsHigh-dose use of supplements affecting wound healingConcurrent use of other topical products on the episiotomy site Occurrence of complications affecting perineal healing during or after childbirth Rapid,difficult, or instrumental delivery Lack of a companion or caregiver in the hospital Unwillingness to continue participation in the study History of psychiatric disorders or postpartum depression Receipt of blood or blood products during or after childbirthProlonged rupture of membranes (more than 24 hours before delivery) O90.1 O70 Disruption of perineal obstetric wound Perineal laceration during delivery Treatment - Drugs Treatment - Drugs Intervention group:Participants allocated to the intervention group will receive routine postpartum care in addition to a topical lotion containing 1% hydroalcoholic extract of jujube fruit (Ziziphus jujuba Mill.). The extract, with 100% purity, will be obtained from the Giah Kala Herbal Refinery. The lotion will be formulated using a standard lotion base and packaged in 25-mL dark-colored bottles.Participants will be instructed to apply approximately 0.5 mL of the 1% jujube lotion as a thin layer over the episiotomy wound twice daily (morning and evening) for 10 consecutive days following childbirth, after cleansing and drying the perineal area. A skin sensitivity test will be performed before initiating the intervention to ensure the absence of allergic reactions. Standardized instructions regarding product application will be provided, and daily reminder messages will be sent to enhance adherence to the intervention protocol Control group:Participants allocated to the control group will receive routine postpartum care in addition to a placebo lotion. The placebo will consist of the same lotion base used in the intervention group but without the jujube extract and will be identical in appearance, odor, consistency, packaging, and storage conditions to ensure blinding.Participants will be instructed to apply approximately 0.5 mL of the placebo lotion as a thin layer over the episiotomy wound twice daily (morning and evening) for 10 consecutive days following childbirth, after cleansing and drying the perineal area. The application procedure, duration of use, participant education, and follow-up schedule will be identical to those of the intervention group. Episiotomy Wound Healing. Timepoint: On postpartum days 1, 5, and 10. Method of measurement: REEDA criteria: R = Redness E = Edema E = Ecchymosis D = Discharge A = Approximation. Pain intensity. Timepoint: On postpartum days 1, 5, and 10. Method of measurement: Visual Analogue Scale. Pain reduction. Timepoint: On postpartum days 1, 5, and 10. Method of measurement: Visual Analogue Scale. Gonabad University of Medical Sciences Approved 2026-04-12 Ethics Committee of Gonabad University of Medical Sciences the roadside of the Asian highway Gonabad Razavi Khorasan Iran (Islamic Republic of)