| CTRI Number |
CTRI/2025/03/081728 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management for Episiotomy Wound(surgical cut made during normal delivery). |
|
Scientific Title of Study
|
Comparative study of Nimba -Madhu ointment and povidine iodine ointment in management of 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 Sameeksha Sanjog Shah |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga), katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9370626365 |
| Fax |
|
| Email |
sameeksha.shah-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul N Gajare |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga), katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890506779 |
| Fax |
|
| Email |
rahul.gajare@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul N Gajare |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga), katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890506779 |
| Fax |
|
| Email |
rahul.gajare@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (deemed to be)university college of ayurved and hospital, katraj, dhankawadi, Pune-411043, India
|
|
|
Primary Sponsor
|
| Name |
Dr Sameeksha Sanjog Shah |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga), katraj-dhankawadi Pune-411043 |
| 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 Sameeksha Sanjog Shah |
Bharati Vidyapeeth (deemed to be University), College of Ayurved and hospital |
Department of prasutitantra evam stree roga,IPD, hospital floor no. 1, katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA |
9370626365
sameeksha.shah-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Ethics Committee[BV(DU)COA-EC] |
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: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nimba-Madhu Ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | povidine iodine ointment | povidine iodine ointment topical application BD dose as per episiotomy wound size for 5 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All primi and multipara who have undergone normal vaginal delivery with episiotomy wound |
|
| ExclusionCriteria |
| Details |
1.Systemic disorders in pregnancy like Diabetes
Mellitus, Hypertension, impaired thyroid
functions.
2.Patients with HIV, HBsAg, VDRL will be excluded.
3.History of impaired wound healing.
4.Patient with third degree and fourth degree perineal tears. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of pain and proper wound approximation. |
Day 1st, 2nd, 3rd and then on 15th day after normal vaginal delivery with episiotomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of episiotomy wound. |
15th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="2"
Months="0"
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
Modification(s)
|
Along with a healthy mother, a healthy baby without any iatrogenic injury is the requirement of an obstetrician, hence an episiotomy becomes inevitable at times. Episiotomy, also known as perineotomy, is a surgical incision of the perineum and the posterior vaginal wall generally done by an obstetrician to shorten 2nd stage of labor and easy delivery of baby. The surgical wound of episiotomy can be considered as SadyoVrana. Different treatment modalities have been told in Ayurveda for Vrana Chikitsa. Thus, in this type of wound, drugs with the properties of Kashaya / Tikta / Madhur rasa, Sheeta and Snigdha guna, can be used. In Ayurveda there are many drugs that have these properties which are used for treating pain at episiotomy wound site. Hereby the chosen drugs Nimba and Madhu have similar properties as vranaropana and vranashodhana which are stated to be good in alleviating pain and thus promote wound healing.
Conduct of procedure: 1. Any subject post vaginal delivery with episiotomy in the Department of Prasuti Tantra Evam Striroga IPD at Bharati Ayurveda Hospital will be considered for this study and confirmed according to inclusion and exclusion criteria. 2. Once the subject is enrolled, all the parameters will be examined and the ointment will be applied as per patient’s requirement. Ointment will be applied locally. Follow up –every day for first five days and then after 15 days. |