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CTRI Number  CTRI/2025/07/090964 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Usefulness of Nimbhadhi ointment in Episiotomy Wound care 
Scientific Title of Study   An Open Label Single Arm Clinical Trial to Evaluate the Effect of Nimabdhi Ointment OF NIMBHAADI OINTMENT IN 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 Avneet Kaur 
Designation  PG Scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh
Oppositie Gurudhawara Sahib Haa Da Nahara Near Grewal Chownk Malerkotla Punjab 148023.
Farrukhabad
UTTAR PRADESH
209602
India 
Phone  6280101751  
Fax    
Email  gurparm22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Bandana Devi 
Designation  Assositiate Proffeser 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh
Shri Babu Singh Jay Singh Ayurvedic Medical college And Hospital, Farrukhabadh.
Farrukhabad
UTTAR PRADESH
209602
India 
Phone  70905200409  
Fax    
Email  bandanapatel01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avneet Kaur 
Designation  PG Scholar 
Affiliation  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh  
Address  Department of PG Studies IN PTSR OPD NO. 10 Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh Bhaupur Bewar Road
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh Bhaupur Bewar Road 209602
Farrukhabad
UTTAR PRADESH
209602
India 
Phone  6280101751  
Fax    
Email  gurparm22@gmail.com  
 
Source of Monetary or Material Support  
Shri Babu singh Jay Singh Ayurvedic Medicalcollege And Hospital Farrukhabad Bhaupur Bewar road 209602 
 
Primary Sponsor  
Name  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital  
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabadh  
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 Avneet Kaur  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital, Bhaupur Bewar Road Farrukhabadh,  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital, Bhaupur Bewar Road Farrukhabadh.209625 Shri Babu Singh Jay Singh Ayurvedic Medical college And Hospital, Farrukhabadh.
Farrukhabad
UTTAR PRADESH 		 06280101751

gurparm22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:1||Obstetrics. Ayurveda Condition: VITAPA-MARMAVIDDHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: SUSHRUTHA SAMHITA ,, Procedure details: Yoni Prakshalan will be done by using Sukhoshna jala & then it was dried with sterile gauze piece. Nimbhadi ointment will be applied on episiotomy wound After application of Drug:- To retained the position at least 10 minutes. Don’t flexed thigh during application of ointment. Maintain local hygiene. )
(1) Medicine Name: NIMBHADI OINTMENT, Reference: SUSHRUTHA SAMHITA ,, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. All primi and irrespective of age with episiotomy
2. Those who are ready to sign the informed and written bilingual consent form
(Hindi and English).
 
 
ExclusionCriteria 
Details  1.Systemic disorders in pregnancy like diabetes mellitus,hypertension etc.
2.subjects with skin diseases.
3.subjects tested positive for HIV, HBsAG,VDRL,HCV.
4.History of impaired wound healing
5.subjects with 3rd and 4th degree perineal tears,perineal hematoma or abscess.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
complete episiotomy wound healing with no complications  2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
nil  no 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2025 
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="1"
Months="2"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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)  
Vaginal mode of delivery is the safest for fetus and mother.  To enhance the space for birth surgical incision known as episiotomy is taken. If proper care of this wound is not taken then complications like wound dehiscence , infections, prolapse,dysperaunia,hematoma etc. may occur.To prevent these complications and for complete healing of episiotomy wound, a clinical trial with nimbadi ointment will be done.Drugs in the nimbadi ointment contains shoolhara, shothahara, krimighna, kushtagana, vranashodhana, vranropana properties.
 
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