跳至主要内容
临床试验/CTRI/2023/05/052787
CTRI/2023/05/052787尚未招募2/3 期

A randomized comparative clinical study of karanja ghrita, nimbadi ointment and betadine ointment along with yoni dhoopana in the management of episiotomy wound.

National Institute Of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Changes in REEDA scale.

研究概览

简要总结

Perineal trauma is a major problem affecting millions ofwomen around the world each year.The degree of perineal pain and discomfortassociated with  perineal trauma is oftenunderestimated. Pain often interferes with daily activites such as walking ,sitting and passing urine and also negatively impacts on motherhoodexperiences. Proper care of episiotomy wound which is already associated with alot of pain is very important  as theparineal area is highly contaminated with lochia, faeces and urine.

The improper care of wound leads to several complications like hemorrhage ,  incontinence of urine and flatus,rectovaginal fistula, wound separation, wound site infection, perineal hematoma,excessive fibrosis etc. Healing by fibrosis may cause dyspareunia and rigidperineum. These complications leads to both physical and psychological problemsand prevents the mothers from enjoying their motherhood.

While several therapies for wound healing like some solutionsand antibiotics are available but these are only moderately effective. Eventhere are many formulations that have failed to achieve the satisfied actionand can cause side effects also.Thus there is a need for more effectivetherapies and formulations for healing wounds.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Both primigravida and multigravida .
  • Patients who will undergo noramal vaginal delivery with episiotomy.
  • Patients with 1st and 2nd degree perineal tear.

排除标准

  • 1.Patients with severe anemia and any systemic disease.
  • 2.Patients with 3rd degree perineal tear.
  • 3.Any skin disease.
  • 4.Patients with positive VDRL, HIV, HBsAg.

结局指标

主要结局

Changes in REEDA scale.

时间窗: 3 months

次要结局

  • not appicable(not applicable)

研究者

申办方类型
Government medical college

研究点 (1)

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