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CTRI Number  CTRI/2023/05/052787 [Registered on: 17/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trail to study the effects of Karanja ghrita, Nimbadi ointment and Betadine ointment along with yoni dhoopana in the management of Episiotomy wound 
Scientific Title of Study   A randomized comparative clinical study of karanja ghrita, nimbadi ointment and betadine ointment along with yoni dhoopana in the management of episiotomy wound. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Chandra 
Designation  M.S. Scholar 
Affiliation  National Institute Of Ayurveda , Jaipur 
Address  Room no 305,Third floor, Department of prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  8385832603  
Fax    
Email  chandrashweta1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBPushpalatha 
Designation  Professor 
Affiliation  National Institute Of Ayurveda , Jaipur 
Address  Room no 305, third floor, Department of Prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Chandra 
Designation  M.S. Scholar 
Affiliation  National Institute Of Ayurveda , Jaipur 
Address  Room no 305,third floor, Department of Prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  8385832603  
Fax    
Email  chandrashweta1997@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda,Zorawer singh gate, Amer road, Jaipur, Rajasthan- 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  Jorawer singh gate , amer road , jaipur 
Type of Sponsor  Government medical college 
 
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 Shweta Chandra  National Institute Of Ayurveda   Room no 305, third floor, Department of Prasuti tantra evum stri roga, National institute of Ayurveda,Jorawer Singh Gate, amer road, Jaipur, Rjasthan
Jaipur
RAJASTHAN 
8385832603

chandrashweta1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O997||Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: sharangdhara samhita, Procedure details: Nimbadi ointment after episiotomy wound bd after food for 15 days)
2Comparator Arm (Non Ayurveda)-betadine ointment application of betadine ointment on episiotomy wound after food bd for 15 days
3Intervention ArmProcedure-lepa, लेप (Procedure Reference: bhavprakash, Procedure details: karanja ghrita aalepa on episiotomy wound after food bd for 15 days)
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Both primigravida and multigravida .
Patients who will undergo noramal vaginal delivery with episiotomy.
Patients with 1st and 2nd degree perineal tear
 
 
ExclusionCriteria 
Details  1. Patients with severe anemia and any systemic disease.
2. Patients with 3rd degree perineal tear.
3. Any skin disease.
4. Patients with positive VDRL, HIV, HBsAg
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in REEDA scale.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
not appicable  not applicable 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/07/2023 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Perineal trauma is a major problem affecting millions of women around the world each year.The degree of perineal pain and discomfort associated with  perineal trauma is often underestimated. Pain often interferes with daily activites such as walking , sitting and passing urine and also negatively impacts on motherhood experiences. Proper care of episiotomy wound which is already associated with a lot of pain is very important  as the parineal area is highly contaminated with lochia, faeces and urine.

The improper care of wound  leads to several complications like hemorrhage ,  incontinence of urine and flatus, rectovaginal fistula, wound separation, wound site infection, perineal hematoma ,excessive fibrosis etc. Healing by fibrosis may cause dyspareunia and rigid perineum. These complications leads to both physical and psychological problems and prevents the mothers from enjoying their motherhood.

While several therapies for wound healing like some solutions and antibiotics are available but these are only moderately effective. Even there are many formulations that have failed to achieve the satisfied action and can cause side effects also.Thus there is a need for more effective therapies and formulations for healing wounds.

 
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