| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O901||Disruption of perineal obstetric wound. Ayurveda Condition: AGANTUJAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |