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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm (Non Ayurveda) | | - | Betadine ointmenr | Betadine ointment will be applied on the surface of sutured episiotomy wound two times a day for 7 days | 2 | Intervention Arm | Drug | Classical | | (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. |