| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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. |