A clinical trail to study the effects of Karanja ghrita, Nimbadi ointment and Betadine ointment along with yoni dhoopana in the management of Episiotomy wound

Phase 2/3

Not yet recruiting

• Conditions: Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: VRANAH,

• Registration Number: CTRI/2023/05/052787
• Lead Sponsor: National Institute Of Ayurveda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in REEDA scale.	3 months

Secondary Outcome Measures

Name	Time	Method
not appicable	not applicable

Trial Locations

Locations (1)

National Institute Of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute Of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Shweta Chandra

Principal investigator

8385832603

chandrashweta1997@gmail.com