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临床试验/CTRI/2025/03/083442
CTRI/2025/03/083442尚未招募2 期

Randomized controlled trial to study the efficacy of Sukshma Triphala vati orally and Nimbapatradi ghrita with madhu local application in Episiotomy wound.

Dr Prajakta Khandoji Shinde1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To study in detail the rate and extent of Episiotomy wound healing after the oral administration of Sukshma Triphala vati 250mg 2BD for 3 days and local application of Nimbapatradi ghrita with Madhu 2-3 gm every 6 hourly for 7 days.

研究概览

简要总结

Study is randomized open labelled clinical trial to assess effect of Sukshma Triphala vati orally and Nimbpatradi ghrita with madhu local application in Episiotomy wound.

Total sample size is 60

There are two groups, and each group has 30 patients

Group A is a trial group and Group B is a control group.

Group A has Sukshma Triphala vati orally 3 days and Nimbapatradi  Ghrita with Madhu local application for 7 days in Episiotomy wound

Group B has Tab Cefixime 200mg orally for 3 days and  Povidine Iodine ointment local application for 7 days in Episiotomy wound

Follow up on - 3rd and 7th day

Analysis of data and Interpretition of result.

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
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Patient aged between 19-35 years 2.Uncomplicated vaginally delivered patients with episiotomy 3.Patient with first and second-degree perineal tear 4.Patients who give informed consent should involve 5.Patient who follow proper protocol should include.

排除标准

  • 1.Patients with labor complications i.e. Extensive perennial tear ,PPH, placental retention etc.
  • 2.Patients of systemic disorders, Instrumental vaginal delivery.

结局指标

主要结局

To study in detail the rate and extent of Episiotomy wound healing after the oral administration of Sukshma Triphala vati 250mg 2BD for 3 days and local application of Nimbapatradi ghrita with Madhu 2-3 gm every 6 hourly for 7 days.

时间窗: At the time of episiotomy taken, on 3rd day and final outcome will be assessed on 7th day

次要结局

  • 1.To evaluate the reduction of pain and associated symptoms during the intervention period in episiotomy wound.(2.To study episiotomy wound from ayurvedic perspective.)

研究者

发起方
Dr Prajakta Khandoji Shinde
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Prajakta Khandoji Shinde

Siddhakala ayurved mahavidyalaya sangamner

研究点 (1)

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