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CTRI Number  CTRI/2023/04/051644 [Registered on: 17/04/2023] Trial Registered Prospectively
Last Modified On: 13/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [wound healing]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management Of Episiotomy Wound with Epiheal Spray 
Scientific Title of Study   A Clinical Study To Compare The Efficacy Of Epiheal- Episiotomy Wound Healing Spray With Betadine Ointment In The Management Of Episiotomy Wound Healing 
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 Poornima Suresh Iyer 
Designation  PG scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Vadodara
GUJARAT
391760
India 
Phone  8999844395  
Fax  02668-260201  
Email  iyerp999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rita Makim 
Designation  Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax  02668-260201  
Email  ritamakim@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rita Makim 
Designation  Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurveda Parul University Limda Waghodia
Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax  02668-260201  
Email  ritamakim@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul University, Vadodara, 391760 
 
Primary Sponsor  
Name  iHub Gujarat M2M Mind to Market 
Address  Prajna Puram KCG Campus opposite PRL Navrangpura Ahmedabad Gujarat 380015 
Type of Sponsor  Government funding agency 
 
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 Poornima Suresh Iyer  parul ayurved hospital  opd no 104 prasuti tantra evum stree roga Parul Ayurveda Hospital Parul University P O Limda Tal Waghodia Gujarat
Vadodara
GUJARAT 		 8999844395
02668-260201
iyerp999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O701||Second degree perineal lacerationduring delivery. Ayurveda Condition: SUTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vraNasyaShaShTi-upakramAH, व्रणस्यषष्टि-उपक्रमाः (Procedure Reference: Anubhuta, Procedure details: Purva Karma ❑ Counselling to the patient. ❑ Written consent will be taken. ❑ Epiheal spray will be kept ready. Pradhan Karma ❑ Patient is asked to empty the bladder and lie in lithotomy position on the examination table. ❑ Episiotomy wound will be cleaned with a sterilized gauze piece ❑ Epiheal Episiotomy wound healing Spray will be sprayed over the wound. Pashchata Karma ❑ Patient is made to lie down for 10 mins after the procedure. ❑ Sanitary Pad to be p)
(1) Medicine Name: Epiheal, Reference: Anubhuta, Route: Topical, Dosage Form: Sprays, Dose: 10(ml), Frequency: bd, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-Betadine ointmentAntiseptic ointment used on wounds.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Parturient women of either primiparous or multiparous, irrespective of the type of suturing, who had full term normal delivery with episiotomy will be selected.
Patients between age 20-35 years will be selected
Those patients who will be ready to sign the informed consent form will be included  
 
ExclusionCriteria 
Details  Patient with H/O PIH
Patient with perineal tear and injury to external genitalia.
Instrumental delivery
High risk Pregnancy
Perineal skin infection
• Diabetes Mellitus
• Anaemia (Hb less than 8g/dl)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wound healing and antiseptic action  Assessment will be done on Day0, Day 7 and Day 14(without medicine) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain relief  Assessment will be done on Daily 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 1/ Phase 2 
Date of First Enrollment (India)   20/04/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Episiotomy is a surgical planned incision on the perineum and posterior vaginal wall during the second stage of labour. It’s also known as perineotomy.It is an inflicted second degree perineal injury.It is the commonest obstetrical operation performed. If proper care is not taken, then chances of it getting infected is high. With infection, dehiscence is a concern. 
As perineal region is highly susceptible to infections due to the proximity of both excretory orifices and vaginal discharges. It is therefore  necessary to take proper care of the wound. Episiotomy wound can be compared to chhinnavrana (a kind of sadhyovrana). The treatment of sadhyovrana is therefore indicated. Aalepa is one among shashtiupakurma which has been incorporated in our classics for better wound healing with minimum scar formation. 
Epiheal spray is a polyherbal spray which will be sprayed over the wound to adhere over it while the drugs act on the wound. 
Thus in the present study the efficacy of Epiheal- Episiotomy wound healing Spray will be observed under aseptic precautions and results will be tabulated in the dissertation.   
 
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