| CTRI Number |
CTRI/2025/10/096082 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Palasha Kshara and udumbaradi taila pichu in the treatment of cervical erosion. |
|
Scientific Title of Study
|
A Randomised Comparative Control Clinical Study of Palasha Kshara and Udumbaradi Taila Pichu in the management of 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 |
Manju Chouksey |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Ayurvedic Studies and Research, Shri Krishna AYUSH Univercity, Kurukshetra, Haryana |
| Address |
Institute of Ayurvedic Studies and Research, Shri Krishna AYUSH Univercity, Umri Road, Sector-8, Kurukshetra, Haryana, 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9887913372 |
| Fax |
|
| Email |
manjuchoksey23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Chairmen, Professor and Head |
| Affiliation |
Institute of Ayurvedic Studies and Research, Shri Krishna AYUSH Univercity, Kurukshetra, Haryana |
| Address |
Institute of Ayurvedic Studies and Research, Shri Krishna AYUSH Univercity, Umri Road, Sector-8, Kurukshetra, Haryana, 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sidheswar Sathua |
| Designation |
Professor and Head |
| Affiliation |
Govt. Dhanwantari Ayurvedic Medical College and Hospital Ujjain Madhya Pradesh |
| Address |
Govt. Dhanwantari Ayurvedic Medical College and Hospital Ujjain Madhya Pradesh 456001
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
8319917193 |
| Fax |
|
| Email |
ssathua8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Dhanwantari Ayurvedic Medical College and Hospital Mangalnath Road Ujjain Madhya Pradesh India 456001 |
|
|
Primary Sponsor
|
| Name |
Dr Manju Chouksey |
| Address |
Govt Dhanwantari Ayurvedic Medical College and Hospital Mangalnath Road ujjain Madhya Pradesh 456001 |
| Type of Sponsor |
Other [Assitant Professor in Govt. Dhanwantari Ayurvedic Medical College and Hospital M. P. ] |
|
|
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 Manju Chouksey |
Govt. Dhanwantari Ayurvedic Medical College and Hospital Ujjain Madhya Pradesh |
Govt. Dhanwantari Ayurvedic Medical College and Hospital Prasuti and Striroga OPD no 45 Chimanganjmandi Ujjain Madhya Pradesh 456006
Ujjain
MADHYA PRADESH |
9887913372
manjuchoksey23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SHRI KRISHNA AYUSH University Kurukshetra Haryana |
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: Palasha Kshara, Reference: Sushrut Sutra Sthana-11, Route: Topical, Dosage Form: Kshara , Dose: 2(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Kshara , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Dhatakyadi Taila Pichu, Reference: Charak Chikitsa Sthana-30, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 14 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palasha Kshara, Reference: Sushrut Sutra Sthana-11, Route: Topical, Dosage Form: Kshara , Dose: 2(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Kshara , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Udumbaradi Taila Pichu, Reference: Charak Chikitsa Sthana-30, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 14 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married patients of age between 21 to 45 years with clinical signs and symptoms of Cervical Erosion and 50% of erosion which will diagnose by the per speculum examination will be registered for the present clinical trial. |
|
| ExclusionCriteria |
| Details |
Patient not fulfilling inclusion criteria, Patient having any anatomical disorder, abnormal discharge due to malignancy, Patient having systemic disease such as diabetes mellitus, HIV, VDRL positive patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will get rid from the disease ( Cervical Erosion) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="62"
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)
|
22/11/2025 |
| 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
|
It is control clinical trial in which 124 patients will be selected on the basis of inclusion and exclusion criteria. Each group contains 62 patients. Cervical Erosion will be assessed daily during application and then after a month for 2 consecutive menstrual cycle. Clinical assessment will be done after completion of 2 consecutive menstrual cycles. The treatment planned on 2nd or 3rd day after bleeding phase of menstrual cycle.is over. In Group A that is trial group Palasha Kshar will apply for 7 sitting on alternate day and Udumbaradi Taila Pichu for 14 days daily. In Group B that is Control group Palasha Kshar will apply for 7 sitting on alternate day and Dhatakyadi taila Pichu for 14 days daily. |