| CTRI Number |
CTRI/2025/07/092030 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Kusthadi varti (wick) in Karnini Yonivyapada (Cervical erosion) |
|
Scientific Title of Study
|
Clinical Evaluation of Role of Kusthadi Varti in the management of Karnini Yonivyapada w.s.r 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 Pooja Sharma |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no 25 ,26 Department of Prasuti tantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8471084205 |
| Fax |
|
| Email |
drpoojasharma08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasuti tantra evum stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no 25,26 Department of Prasuti tantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasuti tantra evum stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no 25,26 Department of Prasuti tantra evum stree Roga Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Sharma |
| Address |
Room no 25,26 Department of Prasuti tantra and street yoga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Sharma |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
Room no 25,26 Department of Prasuti tantra evum stree Roga Vaidya Yagya Dutt sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH |
8471084205
drpoojasharma08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
Approved |
|
|
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 | Procedure | - | vartiH, वर्तिः | (Procedure Reference: Charak Samhita Chikitsathan chapter 30 shloka 70 , Procedure details: Procedure details: Once in a day for 8 days procedure will be done 3 steps Purva Pradhan Paschal karma. PURVA KARMA- In lithotomy position washing vaginal area with normal saline.
PRADHAN KARMA- With the help of fingers loosely packed Kusthadi varti apply locally vaginal route. PASCHAT KARMA- Wash vagina with water.)
(1) Medicine Name: Kusthadi varti , Reference: Charak Samhita Chikitsasthan Chapter 30 shloka 109, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women of reproductive age 18 -45 years
Diagnosed patient of Karnini Yonivyapada |
|
| ExclusionCriteria |
| Details |
Unmarried patients
Pregnant women
Pelvic palpable pathology like cyst, fibroid etc
Major Systemic disorders
HIV, HCV, VDRL, HBsAg positive patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in redness of cervix |
Three courses once in a day for 8 days for 3 consecutive months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in vaginal itching and amount of vaginal discharge |
After analysing all parameters the result will be assessed on the basis of symptomatic relief and improvement.
Partialy improvement after 8 days patient get relief from sign and symptoms
Improvement after 1 month gets 40-50 percent relief from sign and symptom
Improvement after 2 month patient get 60-80 relief from sign and symptom
Get relief after 3 months 80-100 percent from sign and symptoms |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="0"
Months="6"
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
|
If woman straining untimely Vayu gets obstructed by foetus and having combined with kapha and rakta produces prolapse which obstructs the passage of menstrual flow. This is known as karnini. There are several drugs for karnini yonivyapada but here I have chosen Kusthadi varti to reduce recurrences. Therefore I have selected 40 patients aged between 18-45 years, patient should be selected on the basis of inclusion and exclusion criteria. The trial will be 8 days for consecutive 3 months and follow up after 8 days. Cured after 3 months patient gets 80-100 percent relief from sign and symptoms. |