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CTRI Number  CTRI/2026/02/103331 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate Suturing technique of episiotomy continuous and subcutaneous on skin  
Scientific Title of Study   A comparative study of two different seevan karma of skin-Vellitaka and Tunnasevani in pain and healing process of Episiotomy as per REEDA scale and p value 
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 Amruta Baliram Unhale 
Designation  MS Prasutitantra and Striroga 
Affiliation  Sane Guruji Hospital Hadapsar 
Address  MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
Pune
MAHARASHTRA
411028
India 
Phone  7972565528  
Fax    
Email  amrutaunhale70@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Rajput 
Designation  Asso. professor 
Affiliation  Sane Guruji Hospital Hadapsar 
Address  MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
Pune
MAHARASHTRA
411028
India 
Phone  9423978584  
Fax    
Email  drdeepalirajput@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amruta Baliram Unhale 
Designation  MS Prasutitantra and Striroga 
Affiliation  Sane Guruji Hospital Hadapsar 
Address  MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
Pune
MAHARASHTRA
411028
India 
Phone  7972565528  
Fax    
Email  amrutaunhale70@gmail.com  
 
Source of Monetary or Material Support  
Departmentof prasutitantra and streeroga Sane guruji aarogyakendra Malwadi Hadapsar Pune 411028  
 
Primary Sponsor  
Name  Sane guruji arogya kendra 
Address  Sane guruji arogya kendra,malwadi Hadapsar,pune 411028 
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 Amruta Baliram Unhale  sane guruji hospital  MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra MAMS Sumatibhai Shah Ayurveda Mahavidyalya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra And Striroga Sane guruji Aarogya kendra
Pune
MAHARASHTRA 
07972565528

amrutaunhale70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MAMs Sumatibhai shah ayurveda mahavidyala and sane guruji arogya kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O988||Other maternal infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: VRANA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Episiotomy (Procedure Reference: sushruta samhita, Procedure details: Vellitaka & Tunnasevani )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  FTND With irrespective of parity 
 
ExclusionCriteria 
Details  Women with any acute illness like PPH, Haematoma
Women with any chronic illness like DM ,Cardiac disease,skin disease,GDM ,Vaginal cyst
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare to different seevan karama of skin in pain and healing process of episiotomy as per REEDA scale and observing P value  To compare to different seevan karama of skin in pain and healing process of episiotomy as per REEDA scale and observing P value 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the suturing technique in between Vellitaka and Tunnasevani   Study will done by using sushruta samhita and other ayurvedic grantha nearly about 8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   18/02/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Episiotomy wound suturing is considered only for good wound healing as only approximation is needed. But the discomfort, pain,infection ,scar formation ,fibrosis of tissue as it is dependent on how well the approximation is done. 
example , lets consider the suturing technique used is Vellitaka for episiotomy skin , but as one sees , disadvantages -if there failure of any part of suture will result in loosing of whole length and chances of wound gaping is more and perineal area is loaded with bacteria as it may get infected by urine and stool.
-If there is tight suturing then redness and edema will be seen at wound site 
Advantages
.
Well approximated wound with minimal tension 
.
Rapid techinque for closure 
.
Even distribution of tension over the suture line 
if one uses subcutaneous suture (tunnasevani) technique for episiotomy skin then disadvantages - does not hold thin skin 
Adavantages- there will be no space between suture and chances of infection may become less . And foe cosmatic purpose tunnasevani sutures are promptly in use scar is minimal in it .
in classical texts , detail discription suture types , materials ,knot techinque , post operative pain decressing tail,pichu is present millions of women undergo perineal suturing after child birth and type of repair may have an impact on pain and healing so in this study the suturing techinque used in episiotomy wound repair will be compared and analysis will be done for future practicability of it.


 
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