| CTRI Number |
CTRI/2025/07/090374 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the effectiveness of Apamarga Kshara and Tagaradi Taila Vaginal Application for managing eroded cervix. |
|
Scientific Title of Study
|
A Comparative clinical evaluation of effect of apamarga kshara and tagaradi taila yonipichu in the management of karnini yonivyapad 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 Sanju Lata Patel |
| Designation |
MS Scholar (Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic college and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga, State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9451202447 |
| Fax |
|
| Email |
slpatel14792@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shashi Sharma |
| Designation |
Professor and Head of Department |
| Affiliation |
State Ayurvedic college and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga, State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8795545443 |
| Fax |
|
| Email |
shashi.chd98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanju Lata Patel |
| Designation |
MS Scholar (Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic college and Hospital, Tulsidas marg, Turiyaganj, Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga, State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9451202447 |
| Fax |
|
| Email |
slpatel14792@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga, State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India |
| Type of Sponsor |
Government medical college |
|
|
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 Sanju Lata Patel |
State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India 226004 |
PG Department of Prasuti Tantra Evum Stri Roga, State Ayurvedic College and Hospital,Tulsidas marg, Turiyaganj, Lucknow, Uttar Pradesh, India 226004
Lucknow
UTTAR PRADESH |
9451202447
slpatel14792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Committee State Ayurvedic College and Hospital,Lucknow |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagaradi taila yonipichu, Reference: Sushurut Chikitsasthana 2/68, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: For local application on cervix for 7 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apamarga kshara , Reference: Ras tarangini chaturdasha tarang (14/65–66), Route: Vaginal, Dosage Form: Kshara , Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: For local application on cervix at a interval of 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients present with the sign and symptoms of karnini yonivyapada ( cervical erosion) and clinically confirmed on per speculum examination .
2.Age between 22 to 45 years.
3.Married women.
4.Erosion covering more than 25 % area of cervix.
5.Persistent leucorrhea, pelvic pain, backache, contact bleeding.
6.Patients willing to through trial.
|
|
| ExclusionCriteria |
| Details |
1.Unmarried women.
2.Pregnant women, lactating women, women on OCP & PID.
3.Women of age less than 22 and above than 45 Years.
4.Other systemic disorders like hypertension, diabetes, tuberculosis.
5.Patient having any malignant growth.
6.HIV, VDRL, HBsAg positive patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Apamarga kshara in the management of karnini yonivyapad.
2.To evaluate the efficacy of Tagaradi taila yonipichu in the management of karnini yonivyapad.
3.To compare the efficacy of Apamarga kshara with Tagaradi taila yonipichu in the management of karnini yonivyapad. |
1. At interval of 7 days
2. Daily for 7 days
3. At interval of 7 days and daily for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Conceptual study of Karnini Yonivyapad and its modern correlation.
2.To find the safe and potent drug for Karnini Yonivyapad.
3.decrease in white vaginal discharge
4. reduction in cervical erosion.
5.To evaluate any adverse effects associated with treatment. |
1. kshara once a week
2. yonipichu daily for a week
3. kshara once a week and yonipichu daily for a week |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
21/07/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomised, comparative clinical study Phase 2 Parallel group trial. Comparing the efficacy of Apamarga kshara and Tagaradi taila yonipichu in cases of Karnini Yonivyapad for 2 months in 45 patients. The patient fulfilling the clinical criteria for diagnosis of Karnini Yonivyapad will be randomly selected from OPD/IPD of State Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into three groups, Group-A- In this group patients will be treated with Apamarga kshara locally on cervix for 3 sittings for 2 consecutive cycles. Group-B- In this group patients will be treated with Tagaradi taila yonipichu locally for one week after cessation of menses for 2 consecutive cycles. Group-C-In this group patients will be treated with Apamarga kshara locally on cervix once a week along with Tagaradi taila yonipichu locally for one week after cessation of menses for 2 consecutive cycles .Follow up period- 7 days during the treatment and 7days after the completion of trial. |