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CTRI Number  CTRI/2019/05/019010 [Registered on: 09/05/2019] Trial Registered Prospectively
Last Modified On: 06/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE CLINICAL STUDY OF AGNIKARMA AND VIRECHANA KARMA IN THE MANAGEMENT OF KARNINI YONIVYAPAD W.S.R. TO CERVICAL EROSION 
Scientific Title of Study   A RANDOMISED COMPARATIVE CLINICAL STUDY OF AGNIKARMA AND VIRECHANA KARMA IN THE MANAGEMENT OF KARNINI YONIVYAPAD W.S.R. TO CERVICAL EROSION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RICHA TIWARI 
Designation  M S SCHOOLAR 
Affiliation  RICHA 
Address  PG Dept of Prasuti Tantra National Insitute Of Ayurveda Madhav Vilash Place Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9414583139  
Fax    
Email  richa.ayurved@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  National Insitute Of Ayurveda  
Address  PG Dept of Prasuti Tantra National Insitute Of Ayurveda Madhav Vilash Place Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query  
Name  RICHA TIWARI 
Designation  M S SCHOOLAR 
Affiliation  National Insitute Of Ayurveda  
Address  PG Dept of Prasuti Tantra National Insitute Of Ayurveda Madhav Vilash Place Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  09414583139  
Fax    
Email  richa.ayurved@gmail.com  
 
Source of Monetary or Material Support  
OPD.No. 26-27 Dept of Prasuti Tantra National Institute Of Ayurveda Madhav Vilash Plce, Amer Road, Jaipur 
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  P.G.Department of Prasuti Tantra and Stri Roga National Institute of Ayurveda, Madhav Vilas, Amer Road Jaipur- 302002  
Type of Sponsor  Research institution and hospital 
 
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 Richa Tiwari  National Institute Of Ayurveda Jaipur  Dept. of prasuti tantra OPD No.26-27, National Institute Of Ayurveda Madhav Vilash Amer road jaipur 302002
Jaipur
RAJASTHAN 		 09414583139

richa.ayurved@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee National Institute of Ayurveda Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Agnikarma with Shalaka   Agnikarma with Shalaka only for one sitting followed by Ghrita and Madhu in sufficient quantity will be applied over the wound once a day per week for one month.  
Intervention  Virechana karma with Trivrit Lehya   Virechana karma with Trivrit Lehya alongwith Apamarga kshar tail yoni pichu. Pichu size 2X4CM,soaked in 20 ML of Oil. Administration for twice per week for one month after the bleeding phase of menstrual cycle  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  A) Clinically diagnosed patients of cervical erosion (Karnini) on per speculum examination, irrespective of symptoms.
B) Married women irrespective of parity.
C) Age between 20 to 45 years
 
 
ExclusionCriteria 
Details  A) Pregnant women having cervical erosion
B) Women of age less than 20 and more than 45 years
C) Positive patients of Human Immunodeficiency Virus, VDRL and HBs Ag
D) Patients with Intra Uterine Contraceptive Device insertion or on Oral contraceptive pills.
E) Any organic pathology of reproductive tract like endometrial cancer, cervical cancer, cervical intraepithelial neoplasia.
F) Patient having severe systemic disorders like Diabetes, Hypertension, Tuberculosis etc.
G) Patients with Menorrhagia, Metrorrhagia and Polymenorrhoea
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical evaluation of efficacy of Virechna karma in the management of karnini (cervical erosion) and to compare the clinical efficacy of Agnikarma with Virechna Karma in Karnini yonivyapad (Cervical erosion).  evaluation of efficacy of Virechna karma in the management of karnini (cervical erosion). 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate clinical efficacy of Virechna karma procedure by using Trivrit Lehya in karnini (Cervical erosion)  evaluate clinical efficacy of Virechna karma procedure by using Trivrit Lehya in karnini (Cervical erosion) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/07/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In Ayurveda classics almost all of the gynaecological disorders are described under the heading of Yoni vyapad which are twenty in numbers. Karnini yonivyapad is one among them, the description of which seem to be near to Cervical erosion. Normally endocervix is covered by columnar epithelium and ectocervix is covered by squamous epithelium, but in erosion, it is replaced by columnar epithelium. Many of the times infection is the reason for the change in epithelial covering. But sometimes hormonal changes also play a pivotalrole in the changes of epithelial lining, patient suffers with offensive, irritent, profuse vaginal discharge, formation of nabothian folicle,contact bleeding,dyspareunia, intermenstrual bleeding, bowel irritating pelvic pain etc. If it is associated with cevicitis that leads to low back pain. It is also a cause of infertility and constitutional ill-health and sometimes it produces great psychological upset in women. If it is left untreated,in the chronic stages, the columnar epithelium undergoes squamous metaplasia. Its prevalence is more than 50 % of all the gyneacological conditions. In the present study two procedure are selected for comparison purpose in which first is Agnikarma. Second procedure is virechana karma. Acharya Charaka quoted that there is a chance of recurrence in disease treated by shaman therapy but Shodhan therapy cure the disease from its root and there is no chance of recurrence. For that Virchana karma has been selected as a Panchkarma procedure in present study. Virechana karma have been described in various samhitas for yonidosha and granthi chikitsa. there is a need of study to rule out the effective, safer, and economical methods of Doshas shodhna for the managment of cervical erosion. 30 patient suffering from Karnini Yonivyapad (cervical erosion) attending OPD and IPD section of NIA, Jaipur (Raj.) fulfill the inclusion criteria of the study will be randomly selected, irrespective of religion, occupation and soio-economic status. Patients will be randomly divided into two groups (15 patients In each groups). In group A Agnikarma with shalaka will be  done in 15 patients and in group B Virechana karma with Trivrit lehya will be done in 15 patients.  
Agnikarma procedure- The patient is in lithotomy position and the part is cleaned with aseptic solution and draping done. Speculum is to be introduced into the vagina and assessment of the cervical erosion done. Then cervix is to be cleaned. There after Agnikarma done by sterile pre heated shalaka instrument applied to the eroded part of cervix.the sign of Samyaka Dagdha is the Kapota/Talaphalavata and bluish brown colour will be marked.
Virechana karma- First of all Deepana, Pachana, With Panchkol churna (3gm) twice a day before food till appearance of Nirama lakshana. snehpana with Go ghrita till Samyaka snigdha lakshana. Than Virechana karma will be induced by Trivrit lehya. Virechana karma followed by Samsarjana karmaas per the type of Shuddhi.
Trial Drugs- 1.Deepana- Pachana- Panchkola churna(A.H.SU.6/166)  2.Drugs for Virechana karma-Trivrit Lehya (AFI vol.-I Part A Page no. 163-164) (A.H.Kalp 2/9)
colposcopywill be used as the objective parameter. folloe up will be done after 7 days of treatment which will be carried out for 1 month. Assessment will be done on the basis of objective and subjective parameter before treatment, after treatment, and during last follow up. Appropriate statistical test will be applied. 

 
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