Comparative study of Nimba -Madhu ointment and povidine iodine ointment in management of episiotomy wound
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in severity of pain and proper wound approximation.
研究概览
简要总结
Along with a healthy mother, a healthy baby without any iatrogenic injury is the requirement of an obstetrician, hence an episiotomy becomes inevitable at times.
Episiotomy, also known as perineotomy, is a surgical incision of the perineum and the posterior vaginal wall generally done by an obstetrician to shorten 2nd stage of labor and easy delivery of baby.
The surgical wound of episiotomy can be considered as SadyoVrana. Different treatment modalities have been told in Ayurveda for Vrana Chikitsa.
Thus, in this type of wound, drugs with the properties of Kashaya / Tikta / Madhur rasa, Sheeta and Snigdha guna, can be used. In Ayurveda there are many drugs that have these properties which are used for treating pain at episiotomy wound site.
Hereby the chosen drugs Nimba and Madhu have similar properties as vranaropana and vranashodhana which are stated to be good in alleviating pain and thus promote wound healing.
Conduct of procedure:
-
Any subject post vaginal delivery with episiotomy in the Department of Prasuti Tantra Evam Striroga IPD at Bharati Ayurveda Hospital will be considered for this study and confirmed according to inclusion and exclusion criteria.
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Once the subject is enrolled, all the parameters will be examined and the ointment will be applied as per patient’s requirement. Ointment will be applied locally.
Follow up –every day for first five days and then after 15 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •All primi and multipara who have undergone normal vaginal delivery with episiotomy wound.
排除标准
- •1.Systemic disorders in pregnancy like Diabetes Mellitus, Hypertension, impaired thyroid functions.
- •2.Patients with HIV, HBsAg, VDRL will be excluded.
- •3.History of impaired wound healing.
- •4.Patient with third degree and fourth degree perineal tears.
结局指标
主要结局
Reduction in severity of pain and proper wound approximation.
时间窗: Day 1st, 2nd, 3rd and then on 15th day after normal vaginal delivery with episiotomy.
次要结局
- Healing of episiotomy wound.(15th day)
研究者
Dr Sameeksha Sanjog Shah
Bharati Vidyapeeth
