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CTRI Number  CTRI/2025/01/079029 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the effect of one Ayurvedic formulation in Episiotomy wound healing. 
Scientific Title of Study   Evaluation Of Comparative Efficacy Of Murivenna Ointment With Povidone Iodine Ointment In Episiotomy Wound.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Snehal Bapu Borse 
Designation  MS Prasutitantra Evum Streerog Scholar 
Affiliation  Matoshri Asrabai Darade Ayurved College,Babhulgao,Yeola 
Address  OPD No-8 Department Of Prasutitantra evum Streerog, Matoshree Asrabai Darade Ayurved College Babhulgaon ,Tal.-Yeola Dist-Nashik Pin-423401 Maharashtra

Nashik
MAHARASHTRA
423401
India 
Phone  7744805215  
Fax    
Email  snehalborse096@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachin More 
Designation  Professor Prasutitantra evum Streerog Department 
Affiliation  Matoshri Asrabai Darade Ayurved College,Babhulgao,Yeola 
Address  OPD No 8 Department Of Prasutitantra evum Streerog, Matoshree Asrabai Darade Ayurved college Bbhulgaon Tal-Yeola,Dist-Nashik

Nashik
MAHARASHTRA
423401
India 
Phone  9822874480  
Fax    
Email  sachinmore070979@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Snehal Bapu Borse 
Designation  MS Prasutitantra Evum Streerog Scholar 
Affiliation  Matoshri Asrabai Darade Ayurved College,Babhulgao,Yeola 
Address  OPD No 8 Department Of Prasutitantra evum Streerog, Matoshree Asrabai Darade Ayurved college Bbhulgaon Tal-Yeola,Dist-Nashik

Nashik
MAHARASHTRA
423401
India 
Phone  7744805215  
Fax    
Email  snehalborse096@gmail.com  
 
Source of Monetary or Material Support  
Department of Prasutitantra Evum Streerog Matoshree Asrabai Darade Ayurved College Babhulgaon Tal-Yeola Dist.-Nashik Pin-423401 
 
Primary Sponsor  
Name  Matoshree Asrabai Darade Ayurved College Babhulgao Tal-Yeola  
Address  Matoshree Asrabai Darade Ayurved College Babhulgaon Tal.-Yeola Dist-Nashik Maharashtra India Pin-423401 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Snehal Bapu Borse  Matoshri Asrabai Darade Ayurved College Babhulgao Yeola   OPD No.8 Department of Prasutitantra evum Streeroga
Nashik
MAHARASHTRA 
7744805215

snehalborse096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Matoshree Asrabai Darade Ayurved College Babhulgao Yeola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O901||Disruption of perineal obstetric wound. Ayurveda Condition: AGANTUJAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Murivenna Ointment, Reference: The Ayurvedic Formulary Of India, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Before application of ointment local area wash with luke warm water and dry after defecation and micturition then apply ointment.Neither any antibiotic nor any other drug will be given during the treatment period
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Patient of age group
between 18 to 35 years
will be selected.
2) Patients who have
undergone mediolateral
episiotomy sutured wound
will be selected .
3) Both Primi and Multi
para will be selected.
 
 
ExclusionCriteria 
Details  1) All degree perineal tear cases
will be excluded.
2) Patients having blood
coagulopathy, hematoma and
abscess will be excluded.
3) HIV, HbsAg and VDRL
cases will be excluded.
4) Patient having Diabetes
mellitus will be excluded .
5) Patients having HB 8gm%
and below will be excluded.
6)Previous episiotomy
resutured wound,Keloid formed
wound, will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Pain
2)Pricking sensation
3)Redness at wound
4)Oedema at wound
4)Ecchymosis
5)Discharge from Wound
6)Approximation of Wound
7)Tenderness 
Day 0,Day 1,Day 2,Day3,Day 7,Day 10 
 
Secondary Outcome  
Outcome  TimePoints 
Above all the symptoms will be decreased  Maximum 10 days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Postpartum women face lots of difficulties in sitting, walking, standing, and urination also. So, it is very much necessary that perineum shall be healed as soon as possible to avoid complications. In Sutika paricharya, Episiotomy care is also recommended. This surgical wound can be considered on the lines of Sadyovrana and approached accordingly. Acharya Sushruta has mentioned Shashti Upakramas and Sapta Upakramas for the complete management of Vrana. Taila is one among the sixty treatment modalities from the classics that has been beneficial for controlling pain and healing of the wound. Murivenna - a commonly used Anubutha Yoga listed in Kerala Ayurveda pharmacopeia has Vedhanasthapaka and Shothagna effect. The same reference of Murivenna is quoted in Ayurveda Formulary of India (AFI) Part 3[7]. It promotes fast recovery from both fresh and chronic wounds and ulcers. Application of  Ointment is quite easy than oil and it can be applied in any time even during working hours. It is also being a cost-effective therapy. Hence in the present study, the efficacy of Murivenna ointment application on episiotomy wound will be observed under aseptic precaution.
Ayurveda is not only rich in medicine but also in the field of surgery. Acharya Sushruta is the founder of classical Indian surgery, he has discussed the fundamental concepts underlying injuries, wound healing, etc. The delivery process might be simplified by Yoniprasarana (Dilating vulval orifice for easy delivery) by surgical intervention i.e. episiotomy to prevent the aforementioned injuries.  The cut is known as a vitapcheda because it occurs on vitap Pradesh. Episiotomy prevents blood loss, postpartum pelvic floor dysfunction, and perineal and neonatal trauma. Episiotomy is defined as a deliberate incision taken on the perineum and the posterior vaginal wall during the second stage of labour to prevent greater maternal and fetal injurie. Episiotomy is a surgical procedure that is frequently utilized today to facilitate easy delivery of a newborn. In order to increase the vaginal introitus during the second stage of labor, an episiotomy is performed.A straight incision is simpler to repair and heals better than a jagged,uncontrolled laceration.
Restoring the Ayurvedic surgical terms that were described hundreds of years ago might give one’s own abilities and resources when doing surgical procedures. The most frequent presentation during a routine vaginal delivery is the vertex presentation. The birth canal of female body hardly allows engaging the diameter of head in vertex presentation during the process of normal delivery. Because of this, the perineum cannot withstand such a strong force without tearing and lacerating the vaginal wall. According to Ayurveda, Marma & Marma like organ surrounds the Tryavarta Yoni region. Since Vitap marma is located in the inguinal region and damage to it may result in Shandhata, the perineum region is also known as Vitap Pradesh. Injuries to the urethra, anal area, and rectum can happen during vaginal birth. Damage to these organs may result in Vaikalyata. There are many degrees of maternal passageway rips that can result in immediate consequences including hemorrhage, haematoma, infections, tears, and distant complications like urinary incontinence and organ prolapse. Samhitas state that Basti and Guda are Sadhyapranhara Marma. 
 
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