A randomized controlled clinical study to evaluate the prophylactic antiseptic effect of kukubhadi malahar with betadine ointment in the management of prasuta yoni kshata (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
- To evaluate the prophylactic antiseptic effect of kukubhadi malahar in the
研究概览
简要总结
Needfor the study
Prasutaa yonikshatacan be co-related with Episiotomy Wound which is chinna vrana a type of sadhyovrana.In classics it is mentioned that Sadhyovranashould be treated with Kashaya, Madhura Rasa, Sheeta Virya, Snigdha Gunayukta Dravyas for a period of1 week1 . Prasutaa Yoni KshataChikitsa has been explained byAacharyaBhaavamishra in Bhaavaprakash2andAchrayaYogaratnakar3.
Episiotomyis one of the most commonly performed procedures in obstetrics. It is asurgically planned incision on the perineum and the posterior vaginal wallduring the second stage of labour. It is performed to enlarge the vaginalintroitus so as to facilitate easy and safe delivery of the fetus spontaneouslyor manipulative and to minimize overstretching and rupture of the perinealmuscle and fascia to reduce the stress and strain on the fetal head4.
Indeveloped countries efforts have been made to restrict episiotomy practice.However in developing countries the episiotomy rates continue to be high5.
Therate of episiotomy was found to be 93.3% in primipara women and 30.2% inmultipara women6.
Asthe perineum is highly susceptible to infection due to different secretionslike vaginal discharges, faeces, and urine. Episiotomy wound requires a properintervention which could otherwise be self–limiting due to high vascularity ofthe perineal area. If not taken proper care of episiotomy wound may lead toimmediate complications like bleeding, infection, vulval hematoma and wounddehiscence remote complications like dyspareunia, scar endometriosis or chancesof perineal laceration in subsequent labour7.
Episiotomywound care should be started immediately after suturing the wound to reducepain and inflammation. The surgical wound of episiotomy can be considered as Sadyo Vrana8.
In Bhavaprakash SamhitaVrana Shothadhikar Adhyaya theyhave mentioned about VranaRopanadrugs.As mentioned earlier these drugs also having property of Kashaya, Tikta*, Madhur Rasa*, Sheeta Virya and Ruksha,LaghuGuna 9.
Episiotomywound if left untreated, it may land up in DushtaVrana. To overcome this problem, I have selected this topic as theproperties of this Kukubhadi Malaharis Vranaropak,Vrana Shodhana,Vedanasthapak, Shothaghna, Kledashoshak, Krumighnaetc. and the contents are easily available and also easy to prepare, effectiveand cost-effective to patient.
Hencethe present study undertaken to evaluate the efficacy Kukubhadi Malaharin themanagement of *Prasutaa Yoni Kshata (Sadyovrana).*Also effect of Kukubhadi Malahar willbe compared with Betadine ointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •The patients of age group between 20-35 years.
- •All primi and multi gravida.
- •Women who underwent normal vaginal delivery with episiotomy.
排除标准
- •Systemic disorder like Diabetes Mellitus, Hypertension, Pulmonary tuberculosis, Impaired thyroid Functions.
- •Patients with serology positive for HIV, VDRL, HBsAg. Patients with perineal tear.
- •Patients having perineal abscess.
- •Patient with coagulopathies.
- •Hb having less than 8 gm%.
结局指标
主要结局
To evaluate the prophylactic antiseptic effect of kukubhadi malahar in the
时间窗: 6 months
management of prasutaa yonikshata
时间窗: 6 months
次要结局
- To compare the prophylactic antiseptic effect of kukubhadi malahar and betadine ointment in the management of prasutaa yonikshata(6 months)
