| CTRI Number |
CTRI/2025/11/097353 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF
AGNIKARMA WITH PANCHDHATU SHALAKA AND ELECTRIC CAUTRIZATION IN THE MANAGEMENT
OF KARNINI YONIVYAPAD W S R CERVICAL EROSION
|
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF
AGNIKARMA WITH PANCHDHATU SHALAKA AND ELECTRIC CAUTRIZATION IN THE MANAGEMENT
OF KARNINI YONIVYAPAD W S R CERVICAL EROSION
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRPUSHPA GODARA |
| Designation |
2nd year PhD Scholar |
| Affiliation |
Shree Swaminarayan ayurvedic college,Kalol |
| Address |
Post graduate department of Prasuti Tantra Evum Stri Roga Shree
Swaminarayan Ayurvedic College
Gandhinagar
GUJARAT
382725
India |
| Phone |
7027198777 |
| Fax |
|
| Email |
godara.pushpa2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANJANA INGALE |
| Designation |
PROFESSOR AND HOD PTSR |
| Affiliation |
Shree Swaminarayan ayurvedic college,Kalol |
| Address |
Post graduate department of Prasuti Tantra Evum Stri Roga Shree
Swaminarayan Ayurvedic College
Gandhinagar
GUJARAT
382725
India |
| Phone |
9909945110 |
| Fax |
|
| Email |
ranjanaingale7396@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PUSHPA GODARA |
| Designation |
2nd year PhD Scholar |
| Affiliation |
Shree Swaminarayan ayurvedic college,Kalol |
| Address |
Post graduate department of Prasuti Tantra Evum Stri Roga Shree
Swaminarayan Ayurvedic College
Gandhinagar
GUJARAT
382725
India |
| Phone |
7027198777 |
| Fax |
|
| Email |
godara.pushpa2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Premswarup Swami Ayurvedic Multi Speciality Hospital Kalol |
| Address |
Shree Swaminarayan Ayurvedic College and Hospital
Ahmedabad-mehsana Highway At and Po.Saij Ta.Kalol
Dist.Gandhinagar-382725 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PUSHPA GODARA |
NATIONAL COLLEGE OF AYURVEDA |
ROOM NUMBER 6 PTSR DEPARTMENT DIVISION 2
NATIONAL COLLEGE OF AYURVEDA BARWALA
Hisar
HARYANA |
07027198777
godara.pushpa2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National College of Ayurveda & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N99-N99||Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified. Ayurveda Condition: KARNINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | PANCHDHATU SHALAKA AGNIKARMA | (Procedure Reference: Kaviraja Ambikadutta Shastri Commentary Sushruta Samhita of Maharishi Sushruta Published by Chaukhamba Sanskrit Sansthan Varanasi 2021 Sutra Sthana 12/10 , Procedure details: PANCHDHATU SHALAKA AGNIKARAM IN BINDUVAT PATTERN IN ONE SITTING FOLLOWED BY JATYAADI TAIL PICHU DHARAN FOLLOW UP ON 7TH 14TH 21ST 28TH 35TH DAY NO ORAL MEDICATION)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women of reproductive age group twenty one to forty five years of age
Patients with symptoms related to Karnini Yonivyapad
Per speculum examination bright red area surrounds the external os in the ectocervix with clearly demarcated outer edge
Patients who are willing to go for relevant investigations
Pap smear grading 1 2
Cervical Erosion present after three months of delivery or three months after the stoppage of contraceptive pills
Recurrence case of electro-cauterization after three months of treatment
Suitable for Agnikarma
|
|
| ExclusionCriteria |
| Details |
Female patient of age less than 21 years and greater than 45 years / Pt age greater than 40 years with history of menopausal symptoms.
Patients with any diagnosed uterine pathology like Sub-mucosal pedunculated fibroid Adenomyosis Endometrial Polyp, Cervical Polyp etc
Patients with coagulopathy
Patients with pregnancy history of last delivery in duration of three months
Pap smear grading 3 4 5
Diagnosed Systemic illness like genital TB Malignancy Uncontrolled Hypertension Diabetes mellitus etc
Known case of sexually transmitted diseases like VDRL HIV Gonorrhea etc
Unsuitable for Agnikarma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
To evaluate and compare the clinical efficacy of Agnikaram with Panchdhatu Shalaka and Electric Cauterization in management of Karnini Yonivyapad based on
Reduction in clinical signs and symptoms such as Yonigata Srava Yonivedna Yonikandu Yonidaha
Improvement in cervical appearance on per speculam and per vaginal examination
Comparative healing time of cervical lesion
|
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
Assessment of recurrence rate after treatment during follow up period
Evaluation of patient satisfaction & tolerability of both procedures
Comparison of side effects & complications
Improvement in quality of life
|
35 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
In this study I would like to treat the condition of cervical
erosion which I correlate with the
Ayurvedic diagnosis of Karnini Yonivyapada Cervical erosion is described as the
replacement of the squamous epithelium of the ectocervix by the columnar epithelium
of the endocervical canal According to
Ayurvedic view the disease is attributed to vitiation of Vata and Kapha with
involvement of Rakta dhatu the treatment objective is therefore to pacify these
doshas and purify the Rakta The study
design is open label and randomised comparing two groups one treated by thermal
cauterisation via Agnikarma using a Panchdhatu Shalaka and second group treated by electric
cauterisation Outcome measures included relief of symptoms such as discharge
and contact bleeding reduction in size of the erosion and re epithelization of
the cervix My aim is to find out that a
Agnikarma with Panchdhatu Shalaka is how much effective than electric
cauterization in managing Karnini Yonivyapada cervical erosion by destructing the aberrant
epithelium and promoting healthy squamous re epithelialisation
|