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CTRI Number  CTRI/2023/07/055139 [Registered on: 12/07/2023] Trial Registered Prospectively
Last Modified On: 10/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Managment of Karnini Yonivyapad (Cervical Erosion) through Ayurveda. 
Scientific Title of Study   A randomized comparative clinical study to evaluate the efficacy of Palashadi Varti and Pippalyadi Varti in the management of Karnini Yonivyapad w.s.r. 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  Dr Jitesh Kumar Panda 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9896033056  
Fax    
Email  drjk67@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitesh Kumar Panda 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9896033056  
Fax    
Email  drjk67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitesh Kumar Panda 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital 
Address  Room No 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9896033056  
Fax    
Email  drjk67@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Ayush University Kurukshetra Haryana 136118 
 
Primary Sponsor  
Name  Shri Krishna Government Ayurvedic College and Hospital Kurukshetra 
Address  OPD No.15,Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra 
Type of Sponsor  Other [Government Ayurvedic College] 
 
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 Deepika  Shri Krishna Government Ayurvedic College and Hospital  OPD No. 15 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA 
08607131358

deepikajangra08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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. Ayurveda Condition: KARNINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vartiH, वर्तिः (Procedure Reference: Bhaisjya Kalpana Chapter 5 Panchavidh Kashya kalpana, Procedure details: 1.Patient will be lying in lithotomy position. 2.Adhoudar Snehan and Swedan will be given before application of varti. 3.Under aseptic measures Pippalyadi Varti will be inserted in the Yoni. 4. After that Yoni Prakshalana with lukewarm water will be done.)
(1) Medicine Name: Pippalyadi Varti , Reference: Charka Samhita Chikitsha Sathana Chapter 30/72, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-vartiH, वर्तिः (Procedure Reference: Bhaisjya Kalpana Chapter 5 Panchavidh Kashya kalpana, Procedure details: 1.Patient will be lying in lithotomy position. 2.Adhoudar Snehan and Swedan will be given before application of varti. 3.Under aseptic measures Palashadi Varti will be inserted in the Yoni. 4. After that Yoni Prakshalana with lukewarm water will be done.)
(1) Medicine Name: Palashadi Varti, Reference: Charka Samhita Chikitsha Sathana Chapter 30/122, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Married women of reproductive age group (21-45) years of age.
2.Patients with symptoms related to Karnini Yonivyapad(white discharge P/V, Vulval itching and pain)
3.Per speculum examination – reddened area around the external os (Cervical Erosion)
4.Patients who are willing to go for relevant investigations.
 
 
ExclusionCriteria 
Details  1.Patients with any diagnosed uterine organic pathology like Uterine Fibroid, Adenomyosis.
2.Patients with systemic diseases like hypertension, diabetes mellitus etc.
3.Patients with coagulopathy, anaemia, thyroid dysfunction etc.
4.Patients with malignancy or undiagnosed neoplasm.
5.Patients with pregnancy, history of recent delivery (during puerperal period) or abortion.
6.Patients with genital tuberculosis.
7.Patients suffering from sexually transmitted diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in subjective and objective parameters of Cervical Erosion  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Yonigatasrava (Amount of white discharge per vaginum)
2.Yoni kandu(Vulval itching)
3.Udarashula(Lower abdominal pain)
4.Katishula (Lower backache)
5 Mutradaha (Burning micturition)
 
30 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   01/08/2023 
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="0"
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  

 About 85% women suffer from the cervical erosion i.e. benign condition of female genital tract during their lifetime. It is asymptomatic in initial stage but later on it progresses to show many symptoms like white discharge, itching vulva, dyspareunia etc. It adversely affects the physiological & psychological health of women & even interferes in their professional life. It may even lead to infertility. It can show malignant changes in chronic stage . Hence theoretically, treating cervical erosion may prove to be protective against the incidence of cervical cancer. Thus erosion would, by exposing this epithelium, aid an infective process. That’s why it is important to pay attention towards this troublesome disease and to detect these lesions early enough and treat them adequately if cancer of the cervix is to be warded off. Allopathic medicines such as antibiotics and pessaries gave relief for temporarily but patient again developed the same symptoms after cessation of treatment.

Ayurveda offers different kind of treatment modality in the management of Karnini Yonivyapad like Yoni Dhavana/Prakshalana (vulval& perineal toileting), Pichu (tampon), Varti (wick), Lepa (paste), Dhoopana (fumigation), Yoni Purana (filling) and Uttara Basti.

There is a need for an alternative, safe and cost effective remedy in ayurvedic system, as we know Palashadi Varti having Tridoshahara specially Kaphavatahara properties  and Pippalyadi Varti having Teekshna, ushna properties and are also Kaphahara in nature so this research has been undertaken to compare the efficacy of defined drug in Karnini Yonivyapad.

 

 
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