Efficacy of Unani formulation Marham e Katan in comparison with povidone iodine 5 percent ointment on perineal wounds in postpartum women
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wound healing assessed by REEDA (Redness, Edema, Ecchymosis, Drainage, Approximation) Scale
研究概览
简要总结
Title : Efficacy of Unani formulation Marham e katan in comparison with Povidone iodine 5 % ointment on perineal wounds in postpartum women.
Aim : To evaluate the efficacy of Unani formulation Marham e Katan on perineal wounds in postpartum women.
Inclusion criteria : Primiparous /multiparous postpartum women with normal vaginal delivery.
Episiotomy wound and perineal tears (1 and 2 degree according to revised Sultan’s criteria).
Women with normal bleeding and clotting time.
Exclusion criteria : Diagnosed cases of diabetes mellitus and bleeding disorders.
Women with sexually transmitted infections.
Women with 3 and 4 degree perineal tears.
Sample size : 60 (Group A 30 participants , Group B 30 participants)
Intervention : Group A (Marham e Katan)
Group B(Standard povidone iodine 5% ointment)
Group A participants will be treated under aseptic precautions, after cleaning the episiotomy wound /perineal tear Marham e katan will be applied as required, twice a day for 10 days
Group B participants will be treated under aseptic precautions, after cleaning the episiotomy wound/perineal tear standard povidone iodine 5 % ointment will be applied as required , twice a day for 10 days
Outcome: Primary outcome is wound healing assessed by REEDA scale
Secondary outcome is pain relief assessed by VAS scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primiparous or multiparous postpartum women with normal vaginal delivery Episiotomy wound First and second degree perineal tears according to revised sultans criteria.
排除标准
- •Diagnosed cases of diabetes mellitus and bleeding disorders Women with sexually transmitted diseases Women with third and fourth degree perineal tears according to revised sultans criteria.
结局指标
主要结局
Wound healing assessed by REEDA (Redness, Edema, Ecchymosis, Drainage, Approximation) Scale
时间窗: baseline day 0 | weekly twice for 2 weeks
次要结局
- Pain relief assessed by Visual Analog Scale(baseline day 0)
研究者
Dr Yasmeen Fatima
Government Nizamia Tibbi College