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CTRI Number  CTRI/2020/04/024766 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 11/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial on Ayurveda therapies in cervical erosion 
Scientific Title of Study   A Randomized open label comparative clinical study of Agnikarma and Virechana karma in the management of Karnini yonivyapad with special referance 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  DrPratima  
Designation  MS Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of prasuti tantra National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur

Jaipur
RAJASTHAN
302020
India 
Phone  9669468199  
Fax    
Email  chotiprasad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of prasuti tantra National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPratima 
Designation  MS Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of prasuti tantra National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur 302002

Jaipur
RAJASTHAN
302020
India 
Phone  9669468199  
Fax    
Email  chotiprasad@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National institute of ayurveda 
Address  Department of prasuti tantra National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate 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 Pratima  National institute of Ayurveda  Department of prasuti tantra National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur 302002
Jaipur
RAJASTHAN 
9669468199

chotiprasad@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS 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: N72||Inflammatory disease of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP A 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. Triphala Guggulu 500 mg BD for 15 days Orally  
Intervention  GROUP B Virechana karma with Trivrit lehya   Virechana karma with Trivrit Lehya along with Jatyadi tail yoni pichu.Pichu size 2X4CM,soaked in 20 ML of Oil. Administration for twice in a week for one month after completion of the bleeding phase of menstrual cycle. Triphala Guggulu 500 mg BD for 15 days after Virechana karma orally  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Clinically diagnosed patients of cervical erosion (Karnini) by per speculum examination.
2) Patient willing to consenting undergo trial.
3) Married women irrespective of parity.
4) Age between 20 to 45 years
 
 
ExclusionCriteria 
Details  1)Patient not consenting to the trial.
2)Pregnant women having cervical erosion.
3)Patients positive with Human Immunodeficiency Virus, VDRL and HBs Ag
4)Patients with Intra Uterine Contraceptive Device insertion or on Oral contraceptive pills.
5)Any organic pathology of reproductive tract like endometrial cancer, cervical cancer, cervical intraepithelial neoplasia.
6)Patient having severe systemic disorders like Diabetes, Hypertension, Tuberculosis etc.
7)Patients with Menorrhagia, Metrorrhagia and Polymenorrhoea.
8)Patient having second and third degree of uterus prolapse.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the cervical erosion on Colposcopic assessment .  8 Week 
 
Secondary Outcome  
Outcome  TimePoints 
To relief in associated symptom like white discharge p/v, lowback pain etc.
 
8 Week 
 
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)   01/05/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Gynecological disorders are those disorders that affect the female reproductive system. Cervical erosion is one of them. 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 change in epithelial covering. But sometimes hormonal changes also play a pivotal role in the changes of epithelial lining, patient suffers with offensive, irritant, profuse vaginal discharge, formation of nabothian follicle, contact bleeding, dyspareunia, intermenstrual bleeding, bowel irritating pelvic pain etc. If it is associated with cervicitis 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.

In Ayurveda classics almost all of the gynecological disorders are described under the topic of yonivyapad which are twenty in numbers.Karnini Yonivyapadis one among them, seems to be near to Cervical erosion. . Its prevalence is more than 50% of all the gynecological conditions

 In the present study two procedures are selected for comparison purpose in which first is Agnikarma and second 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 Virechana karma has been selected as a Panchkarma procedure in present study.Virechana karma have been described in various Samhitas for Yonidosha .and GranthiChikitsa.  There is need of study to rule out the  effective, safer and economical methods of  Doshas shodhna for the management of cervical erosion. 30 patients suffering from  karnini Yonivyapad (Cervical erosion) from OPD & IPD National Institute of Ayurveda, Jaipur will be selected  according to the inclusion criteria , irrespective of religion, occupation and socio-economic status. Patients will be randomly divided into two groups. In group A  Agnikarma with shalaka  and group B Virechana karma  with Trivrit lehya. 

Agnikarma procedure - The patient is in lithotomy position and the part is cleaned with aseptic solutions 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 procedure -  First of all  Deepana ,Pachna with Panchkola churna(3gm ) twice a day before food till apperances of Nirama lakshana,snehapana with Go ghrita till samyaka snigdha lakshna. than virechana  karma will be induced by  Trivrit lehya. Virechana karma followed by Sansarjana karma per the type of shuddhi.

Colposcopy will be used as the objective parameter, follow 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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