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CTRI Number  CTRI/2025/07/091101 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A trial to study the effect of Bhavprakashokta panchakashay yonivarti dharan in Karnini Yonivyapada (Cervical erosion). 
Scientific Title of Study   A randomised controlled clinical trial to study the effect of Bhavprakashokta Panchakashay Yonivarti Dharan in Karnini Yonivyapada with special reference to 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  Dr Neha Hemant Phirke 
Designation  PG Scholar 
Affiliation  Yashwantrao Chavan Ayurvedic Medical College and Hospital 
Address  OPD no. 110 Prasutitantra evum Streeroga department Yashwantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431007
India 
Phone  7774849504  
Fax    
Email  sonalfirke99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ketan G Jangale 
Designation  Professor  
Affiliation  Yashwantrao Chavan Ayurvedic Medical College and Hospital 
Address  OPD no. 110 Prasutitantra evum Streeroga department Yashwantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431007
India 
Phone  8805642026  
Fax    
Email  ketan.jangale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Hemant Phirke 
Designation  PG Scholar 
Affiliation  Yashwantrao Chavan Ayurvedic Medical College and Hospital 
Address  OPD no. 110 Prasutitantra evum Streeroga department Yashwantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431007
India 
Phone  7774849504  
Fax    
Email  sonalfirke99@gmail.com  
 
Source of Monetary or Material Support  
Yashwantrao chavan ayurvedic medical College and hospital nipani bhalgaon beed by pass road, chhatrapati sambhajinagar, Maharashtra India 431007 
 
Primary Sponsor  
Name  Neha Hemant Phirke 
Address  OPD no. 110 prasutitanra evum streeroga department, Yashwantrao chavan ayurvedic medical College and hospital nipani bhalgaon, beed by pass road chhatrapati sambhajinagar Maharashtra India Pin no. - 431007 
Type of Sponsor  Other [Self ] 
 
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 Neha Hemant Phirke  yasheantrao chavan ayurvedic college and hospital  OPD no. 110 Prasutitantra evum streeroga department, yashwantrao chavan ayurvedic college and hospital, nipani bhalgaon, beed bypass rd, Chh. sambhajinagar
Aurangabad
MAHARASHTRA 
7774849504

sonalfirke99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee Yashwantrao chavan ayurvedic medical College and hospital   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 ArmDrugClassical(1) Medicine Name: Panchakashay yonivarti, Reference: Bhavprakash samhita, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 6 Days, Reference: No, Route: -, Dosage Form: Varti/ Suppository, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator Arm (Non Ayurveda)-Clotrimazole 100mg vaginal pessaryclotrimazole 100mg vaginal pessary 1 pessary will be inserted vaginally once a day for 6 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Married female patients
Diagnosed and confirmed patient of cervical erosion having nonpurulent vaginal discharge  
 
ExclusionCriteria 
Details  Benign or malignant lesion of cervix
Patient having uterine prolapse
Hysterectomy patients
Early menopausal women
Pregnant women
HIV VDRL HBSAG positive patients
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of bhavprakashokta panchakashay yonivarti dharan in karnini yonivyapad   6 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the literature of karnini yonivyapad w.s.r. to cervical erosion in details by ayurvedic and modern perspective.
To study litrature of bhavprakashokta panchakashay gan. 
18 months  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   30/07/2025 
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)   Not Yet Recruiting 
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  
Normal vaginal secretions consist of white coagulated material involving doderlein’s bacilli, squamous cells and coagulated secretions. The vaginal contents are mostly derived from squamous cells of the vaginal mucosa. Some, from endometrial and cervical
secretions. Pathological conditions such as cervical erosion causes increased mucus secretion and patient complaints of mucous discharge at vaginal orifice. In leucorrhoea, the normal vaginal secretions are increased in amount. In such
patients there will be no excess of leucocytes present, and discharge is non purulent. Purulent discharges are due to specific infections such as tricomoniasis, moniliasis and
gonorrhoea. Ulcerated growths of cervix and discharges caused by urinary fistula are of different type and are excluded from term “leucorrhoea”. Increases in normal vaginal
secretions is physiological in pregnancy, puberty, and premenstrual phase of menstrual cycle. Non-pathogenic leucorrhoea can be classified into 1) cervical and 2) vaginal.
Discharge from endocervical glands increases in conditions such as chronic cervicitis, cervical erosion, mucous polypi, and ectropion.
Cervical erosion is benign condition if left untreated may lead to infertility and cervical malignancy.
Cervical erosion resembles to karnini yonivyapada according to ayurvedic texts. In ayurvedic classics it is mentioned that non-purulent vaginal discharge is caused due to consumption of kaphakara aahara and vihara.
Hence kaphashamaka treatment is needed to subside the symptom. According to aacharya charak and vagbhatta, vata-kapha
doshas are involved in karnini yonivyapada whereas according to aacharya sushruta, only kapha dosha along with rakt is involved and other kaphaj features like unctuousness, itching, etc are seen.
In following study, one attempt will be made by using a formulation
(panchakashaya) described by Bhavaprakasha for symptom Yonipichilta in karnini Yonivyapad, to rule out its effect by using its choorna’s yonivarti.
 
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