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临床试验/CTRI/2025/01/078841
CTRI/2025/01/078841尚未招募4 期

A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Local Application Of Manjishthadi Taila In The Management Of Vitapa Cheda With Special Reference To Episiotomy Wound.

Bhagyashri Bhanudas Patil1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Standardized REEDA Scale

研究概览

简要总结

In the present times, During vaginal deliveries ,Episiotomy A surgically planned incision on perineum and posterior Vaginal wall during the 2nd stage of labour to facilitate easy & safe Vaginal delivery of baby is routinely administered.

Although in Ayurvedic Samhita, description of Episiotomy wound has not been given directly but vrana (wound) is described very well and hence it can be considered as shuddha Agantuja sadyo vrana or Vaidyakrita vrana and also it can be considered as Sukhsadhya Vrana.

In Ayurveda, Various drugs are mentioned for external application and internal administration in context of vrana.

we can corelate Episiotomy wound with sadhyavrana and if it is left untreated it may lead to dushta vrana which can affect the quality of life.

Postpartum women faces a lot of difficulties in sitting ,walking, standing & urination also, So it is very much necessary that perineum shall be healed as soon as possible to avoid the complications such as pain, swelling, discomfort ,sepsis, discharge which interferes with women’s daily activity.

Manjishthadi taïla acts as Varnya, shothahar, Kledshoshak, Vedanasthapak, kandughna, krumighna, Jantughna because of its Tikta, katu, kashay Rasa So keeping all this in mind Manjishthadi á¹­aila is being selected For study.

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

  • 1.All Primi & Multipara who undergone Normal vaginal delivery with Episiotomy wound.
  • 2.Age group -18 to 40 years.
  • 3.Voluntary willing patients.
  • 4.Patients irrespective of religion, cast, socio-economic status, occupation.

排除标准

  • 1.Forceps & Vaccum delivery.
  • 2.All degree perineal tears.
  • 3.Patients having perineal hematoma or abscess.
  • 4.Patients having HIV, HBsAg, HCV, VDRL Positive.
  • 5.Patients with DM, HTN 6.Moderate (7-8.9 gm/dl HB) & Severe (less than 7 gm/dl HB ) Anaemic patients.

结局指标

主要结局

Standardized REEDA Scale

时间窗: 10 days

(REEDA- Redness, edema, ecchymosis, discharge, approximation

时间窗: 10 days

次要结局

  • 1.Vrana Vedana -Pain(2.Vrana Shotha -Inflammation)

研究者

发起方
Bhagyashri Bhanudas Patil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bhagyashri Bhanudas Patil

APMs Ayurved Mahavidyalaya Sion

研究点 (1)

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