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临床试验/CTRI/2025/12/099082
CTRI/2025/12/099082招募中不适用

Efficacy of Roghan-e-Raal Versus Povidone-Iodine Ointment in Perineal Wound Healing in Postpartum Women: A Randomized Standard Controlled Study

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1

研究概览

简要总结

Postpartum women with episiotomy or 1st or 2nd degree perineal tear will be selected (n=64), and written informed consent will be obtained before the study. The initial assessment of REEDA and VAS will be conducted immediately before the intervention (four hours after delivery). After intervention, REEDA and VAS assessment will be performed 24 hours, 48 hours, and 10-14 Days after episiotomy/perineal tear. In the test group, externally Roghan-e-Raal, 2g twice daily for 10 days, will be applied to the perineal wound. In the control group, povidone-iodine (5%) will be applied 2g twice a day for 10 days.All of them will receive an injection of Ceftriaxone 1 g stat in the intrapartum period. In the postnatal period, analgesic (diclofenac 50 mg) will be given SOS for 5 days as rescue medicine. Participants fulfilling the inclusion criteria mentioned above will be given the information sheet, which has details regarding the nature of the study and the drugs to be used. Participants will be given enough time to go through the study details mentioned in the information sheet. They will be allowed to ask any questions, and if they agree to participate in the study, they will be asked to sign the informed consent form. The appropriate tests will be applied to analyse the data. Descriptive statistical analysis will be used in the study. Results on continuous measurements will be presented in mean (SD), and results on the categorical measurements will be presented in number (%) with 5% level of significance and 95% confidence Interval.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Primiparous or multiparous women
  • Live singleton pregnancy with 37-42 weeks of gestation with cephalic presentation.
  • Episiotomy or 1st degree or 2nd degree perineal tear.

排除标准

  • Sensitivity to Roghan-e-Raal.
  • History of chronic systemic diseases hindering wound healing (e.g., coagulation disorders, diabetes, and severe anaemia (Hb less than 7 gm/dl).
  • Postpartum women with perineal hematoma, third or fourth degree perineal tear.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Farhat Quamar

National Institute of Unani Medicine

研究点 (1)

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