| CTRI Number |
CTRI/2026/02/104294 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating The Effectiveness Of Samangadi Tail In Healing Episiotomy Wound A Randomised Controlled Clinical Study On Vitapcheda . |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Local Application Of Samangadi
Tail In The Management Of Vitapcheda W.S.R. To Episiotomy Wound . |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Srushti Sanjay Dhabugade |
| Designation |
PG Scholar In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic College Hospital And Research Centre Gadhinglaj,Kolhapur |
| Address |
Stree Roga Evum Prasuti Tantra OPD No.5 And IPD, Ground Floor Late Kedari Redekar Ayurvedic College, Hospital And Research Centre P2 M.I.D.C. Shendri Mal, Gadhinglaj Dist- Kolhapur 416502 Maharashtra India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9579706544 |
| Fax |
|
| Email |
srushtidhabugade212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prasad Uttamrao Lomate |
| Designation |
BAMS PG (Dip) Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic College Hospital and Research Centre Gadhinglaj ,Kolhapur |
| Address |
Stree Roga Evum Prasuti Tantra OPD No.5 And IPD,Ground Floor Late Kedari Redekar Ayurvedic College,Hospital And Research centre P2 M.I.D.C. Shendri Mal Gadhinglaj
Dist-Kolhapur Maharashtra
416502 India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8275917687 |
| Fax |
|
| Email |
prasadlomate969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srushti Sanjay Dhabugade |
| Designation |
PG Scholar In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic College Hospital And Reserach Centre Gadhinglaj ,Kolhapur |
| Address |
Stree Roga Evum Prasuti Tantra OPD No.5 And IPD,Ground Floor Late Kedari Redakar Ayurvedic College, Hospital And Research Centre Gadhinglaj 416502 Kolhapur Maharashtra 416502
India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9579706544 |
| Fax |
|
| Email |
srushtidhabugade212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College ,Hospital And Research Centre P2 M.I.D.C.Shendri Mal ,Gadhinglaj-416502 District-Kolhapur, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Srushti Sanjay Dhabugade |
| Address |
Behind Maruti Temple varche Gali Tasgaon , Tal-Tasgaon 416312 District- Sangli ,Maharashtra, India Maharashtra 416312 India |
| Type of Sponsor |
Other [self] |
|
|
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 Srushti Sanjay Dhabugade |
Late Kedari Redekar Ayurvedic Hospital And Research Centre Gadhinglaj Kolhapur |
Department Of Stree Roga Evum Prasuti Tantra OPD No-5 And IPD, Ground Floor, Late Kedari Redekar Ayurvedic College ,Hospital And Research Centre P2 M.I.D.C. Shendri Mal, Gadhinglaj 416502,Dist- Kolhapur, Maharashtra
India
Kolhapur
MAHARASHTRA |
9579706544
srushtidhabugade212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Hospital And Research Centre Gadhinglaj Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O860||Infection of obstetric surgical wound. Ayurveda Condition: VITAPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Samangadi taila , Reference: Susharuta Samhita Chikistastan, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -no | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidine Iodine 5% | Medicine Name-Povidine Iodine 5%,Route- Topical,Dose- 3ml,Frequency-BD,Duration- 10days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous women with normal vaginal delivery with episiotomy Multiparous women with normal vaginal delivery with episiotomy Age group 18to40 Voluntary willing patient |
|
| ExclusionCriteria |
| Details |
Patient having perineal heamatoma or abscess Patient having serology positive for HIV VDRL HBsAg Patient with systemic disorder like diabetes mellitus 3rd and 4th degree perineal tear |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vranaropan |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vranavedana (pain) Vranashotha(inflammation) Vranastrav(discharge) Vranagandha(foul smell) |
10 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="6"
Days="0" |
|
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
|
Pregnancy and childbirth are critical phases that greatly influence a womans physical and mental health especially during postpartum period known in ayurveda as sutikakal .This period demands specialised care to aid recovery after the physical strain of vaginal delivery. In modern obstetrics an episiotomy a surgical incision made during labor facillitate childbirth but often results in the wounds that can cause pain swelling and discomfort impacting daily activities. While classical ayurvedic texts do not directly mention episiotomy they extensively describe wound type vrana and their treatment . Samangadi tail a traditional ayurvedic formulation possesses properties such as wound healing vranaropak pain relief vedanastapak anti-inflammatory shothaghna and antimicrobial effects. This study explore its effectiveness in promoting faster healing of episiotomy wounds aiming to reduce postpartum discomfort and improve early maternal well being |