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CTRI Number  CTRI/2025/06/088540 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Kukubhadi ointment application in Episioty wound 
Scientific Title of Study   A randomized controlled clinical study to evaluate the prophylactic antiseptic effect of kukubhadi malahar with betadine ointment in the management of prasuta yoni kshata (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 Gholap Abhishek Ashok  
Designation  PG Scholar  
Affiliation  Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital department of prasuti tantra evm streeroga koppal

Koppal
KARNATAKA
583231
India 
Phone  7021971263  
Fax    
Email  abhigholap211@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Supriya MS 
Designation  Professor and HOD  
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital department of prasuti tantra evm streeroga koppal

Koppal
KARNATAKA
583231
India 
Phone  9480010072  
Fax    
Email  drsupriyaprashanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Supriya MS 
Designation  Professor and HOD  
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital department of prasuti tantra evm streeroga koppal


KARNATAKA
583231
India 
Phone  9480010072  
Fax    
Email  drsupriyaprashanth@gmail.com  
 
Source of Monetary or Material Support  
Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital department of prasuti tantra evm stree roga koppal, Karnataka, 583231 
 
Primary Sponsor  
Name  Dr Gholap Abhishek Ashok 
Address  Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital department of prasuti tantra evm stree roga koppal 
Type of Sponsor  Other [Self] 
 
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 Gholap Abhishek Ashok  Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal  OPD No 16, Dept of Prasuti tantra evam streeroga
Koppal
KARNATAKA 
7219183283

abhigholap211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N80-N98||Noninflammatory disorders of female genital tract. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Betadine ointmenrBetadine ointment will be applied on the surface of sutured episiotomy wound two times a day for 7 days
2Intervention ArmDrugClassical(1) Medicine Name: Kukubhadi Malahar , Reference: Bhavaprakash Samhita vranashothadikar, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Kukubhadi Malahar will be applied on the surface of sutured episiotomy wound two times a day for 7 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  The patients of age group between 20-35 years.
All primi and multi gravida.
Women who underwent normal vaginal delivery with episiotomy. 
 
ExclusionCriteria 
Details  Systemic disorder like Diabetes Mellitus, Hypertension, Pulmonary
tuberculosis, Impaired thyroid Functions.
Patients with serology positive for HIV, VDRL, HBsAg.
Patients with perineal tear.
Patients having perineal abscess.
Patient with coagulopathies.
Hb having less than 8 gm% 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the prophylactic antiseptic effect of kukubhadi malahar in the
management of prasutaa yonikshata  
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the prophylactic antiseptic effect of kukubhadi malahar and betadine ointment in the management of prasutaa yonikshata   6 months 
 
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)   21/06/2025 
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="0"
Months="6"
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  

Need for the study 

Prasutaa yonikshata can be co-related with Episiotomy Wound which is chinna vrana a type of sadhyovrana. In classics it is mentioned that Sadhyovrana should be treated with Kashaya, Madhura Rasa, Sheeta Virya,  Snigdha Gunayukta Dravyas for a period of 1 week1 . Prasutaa Yoni Kshata Chikitsa has been explained byAacharya Bhaavamishra in Bhaavaprakash2andAchrayaYogaratnakar3.

Episiotomy is one of the most commonly performed procedures in obstetrics. It is a surgically planned incision on the perineum and the posterior vaginal wall during the second stage of labour. It is performed to enlarge the vaginal introitus so as to facilitate easy and safe delivery of the fetus spontaneously or manipulative and to minimize overstretching and rupture of the perineal muscle and fascia to reduce the stress and strain on the fetal head4.

In developed countries efforts have been made to restrict episiotomy practice. However in developing countries the episiotomy rates continue to be high5.

The rate of episiotomy was found to be 93.3% in primipara women and 30.2% in multipara women6.

As the perineum is highly susceptible to infection due to different secretions like vaginal discharges, faeces, and urine. Episiotomy wound requires a proper intervention which could otherwise be self–limiting due to high vascularity of the perineal area. If not taken proper care of episiotomy wound may lead to immediate complications like bleeding, infection, vulval hematoma and wound dehiscence remote complications like dyspareunia, scar endometriosis or chances of perineal laceration in subsequent labour7.

Episiotomy wound care should be started immediately after suturing the wound to reduce pain and inflammation. The surgical wound of episiotomy can be considered as Sadyo Vrana8.

In Bhavaprakash  SamhitaVrana Shothadhikar Adhyaya they have mentioned about VranaRopana drugs.As mentioned earlier these drugs also having  property of Kashaya, Tikta, Madhur Rasa, Sheeta Virya and Ruksha,Laghu Guna 9.

Episiotomy wound if left untreated, it may land up in Dushta Vrana. To overcome this problem, I have selected this topic as the properties of this Kukubhadi Malahar is Vranaropak,Vrana Shodhana,Vedanasthapak, Shothaghna, Kledashoshak, Krumighna etc. and the contents are easily available and also easy to prepare, effective and cost-effective to patient.

Hence the present study undertaken to evaluate the efficacy Kukubhadi  Malaharin the management of Prasutaa Yoni Kshata (Sadyovrana). Also effect of Kukubhadi Malahar will be compared with Betadine ointment.

 
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