| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: | | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole 100mg vaginal pessary | clotrimazole 100mg vaginal pessary
1 pessary will be inserted vaginally once a day for 6 days |
|
|
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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
|
|
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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
|
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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. |