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CTRI Number  CTRI/2025/07/090675 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Healing episiotomy wound with ayurveda:A study on the effectiveness of Yashtimadhu siddha ghrit application. 
Scientific Title of Study   Assessment of the Efficacy of Local Aplication Of Yashtimadhu Siddha Ghrit in Vitapchhed Vrana with special reference to Episiotomy Wound: Randomized Control Trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragati Pradip Mulik 
Designation  PG Scholar 
Affiliation  PMTs Ayurved College, shevgaon. 
Address  OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
OPD NO. 107, PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India 
Phone  7218050186  
Fax    
Email  mulikpragati4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr prakash Kanade 
Designation  Professor and HOD 
Affiliation  PMTs Ayurved College, shevgaon. 
Address  PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9881413123  
Fax    
Email  prkanade73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr prakash Kanade 
Designation  Professor and HOD 
Affiliation  PMTs Ayurved College, shevgaon. 
Address  OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9881413123  
Fax    
Email  prkanade73@gmail.com  
 
Source of Monetary or Material Support  
OPD NO. 107, STREERAG AND PRASUTITANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurved College shevgaon,tal- shevgaon, dist-ahmadnagar.414502 
 
Primary Sponsor  
Name  PMTs Ayurved College, Shevgaon 
Address  Shevgaon,Tal-Shevgaon,Dist-Ahmadnagar, Maharashtra414502 
Type of Sponsor  Private 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 Pragati Pradip Mulik  PMTs Ayurved College, Shevgaon  OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar.
Ahmadnagar
MAHARASHTRA 
7218050186

mulikpragati4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O94-O9A||Other obstetric conditions, not elsewhere classified. Ayurveda Condition: VITAPA-MARMAVIDDHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: yashtimadhu siddha ghrit, Reference: yogratnakar sdhyovrana chikitsa 4, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Nimba Tail, Reference: kaiyadeva nighantu 4, Route: Topical, Dosage Form: Dravaka, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Dravaka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All primi & multigravida whounderwent vaginal delivery with episiotomy. Patients have first and second degree perineal tear. 
 
ExclusionCriteria 
Details  Systemic disorders in pregnency like DM, HTN, pulmonary TB, impaired thyroid functions. patients with third and fourth degree perineal tears. patients with serology positive for HIV, VDRL, HBsAG. patients having perineal haematoma or abscess. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Yashtimadhu siddha ghrit in episiotomy wound.  7 days treatment with 9 follow up on 1,2,3,4,5,6,7,10 & 15th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Nimba tail in episiotomy wound.
To compare the effect of yashtimadhu siddha ghrit and nimba tail in episiotomy wound healing.
To observe adverse effect of drugs during the procedure. 
7 days treatment with 9 follow up on 1,2,3,4,5,6,7,10 & 15th day. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   25/07/2025 
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="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  

Episiotomy is planned surgical incision given in the medial or medio-lateral aspect of the perineum to reduce the maternal and neonatal trauma and morbidity associated with delivery. It has short term benefits of episiotomy for doctors is easy to repair compared to a spontaneous perineal lacerations. It also decreases postpartum pain and reduction in severe or 3rd and 4th degree perineal tears. Now days the term episiotomy comes into Conside- ration because the perineal tears can gives many complications, like infection, sepsis. But healing becomes problematic even after suturing (as the vaginal PH becomes alkaline in post partum period acc. to modern science) there may be soiling by fecal matter and gives complications.The degree of perineal pain and discomfort associated with preineal tear is often underestimated. Pain often interferes with basic daily activities of the woman such as walking, sitting and act of micturition and that of defecation and also negatively impact on motherhood experiences. Hence a timely intervention of episiotomy can prevent the maternal morbidity.

During post natal period, puerperal sepsis is one of the major concern. As the perineum is highly susceptible to infection due to different secretions like vaginal discharges, faeces and urine, episiotomy wound requires a proper care which could otherwise be self limiting due to high vascularity of perineal area. If not taken care , episiotomy wound may lead to immediate complications like infection, dehiscence or remote complications like dyspareunia, scar endometriosis or chances of perineal lacerations in subsequent labour.

Episiotomy wound can be compared to Chhina Vrana(a type of Sadhyo Vran) and treatment can be planned as that of sadhyo vran. Acharya Sushruta has mentioned Shashti Upakrama for Vrana Chikitsa for better healing and pain management, where alepana being one among them.

Thus, a sincere attempt has been made in the present study to hasten the rate of episiotomy wound healing by application of Yashtimadhu Siddha Ghrit.


 
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