| CTRI Number |
CTRI/2025/09/094982 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study on the effect of kushtadi vaginal suppository and panchvalkal kwath vaginal douche in management of cervical erosion |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Kushtadi Yonivarti And Panchvalkal Kwath Yoniprakshalan in 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 Chini Jain |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of Prasuti tantra evum stri roga , O.P.D. No. 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan , Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7225050917 |
| Fax |
|
| Email |
chinijain14216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Agrawal |
| Designation |
H.O.D. & Professor In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of Prasuti tantra evum stri roga , O.P.D. No. 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9425431802 |
| Fax |
|
| Email |
Sureshagrawal124@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Agrawal |
| Designation |
H.O.D. & Professor In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of Prasuti tantra evum stri roga , O.P.D. No. 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9425431802 |
| Fax |
|
| Email |
Sureshagrawal124@gmai.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Ayurved Pg college and hospital , Bhopal , Madhya Pradesh , India |
|
|
Primary Sponsor
|
| Name |
Dr Chini Jain |
| Address |
P.G. Scholar , Prasuti tantra evum stri roga department , Rani Dullaiya Ayurved Pg college and hospital , Bhopal , Madhya Pradesh , India , 462044 |
| 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 Chini Jain |
Rani dullaiya smriti ayurved Pg college Hospital |
Dept. of Prasuti tantra evam stri roga Rani Dullaiya Smriti PG Ayurved College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH |
7225050917
chinijain14216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comitee , Rani dullaiya smriti ayurveda pg college evam chikitsalaya , Bhopal , M.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease 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: Kushtadi , Reference: charak samhita , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 6(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Kushtadi yoni varti in karnini yonivyapad | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchvalkal , Reference: Sharangdhar samhita , Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 1000(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Panchvalkal kwath prakshalan in karnini yonivyapad |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Clinically diagnosed and confirmed patients of cervical erosion ,reproductyive age group females ,known case of bacterial vaginosis and vaginal candidiasis |
|
| ExclusionCriteria |
| Details |
mensturating women , pregnancy , known case of malignancy , uterine prolapse ,Hepatitis A, B,C,D,E , HIV 1& 2 , TB |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To treat the patient of cervical erosion along with comparing efficacy of kushtadi yoni varti and panchvalakal kwath yoni prakashalan |
21 days trial of each patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of kushtadi yoni varti and panchvalakl kwath prakashalan in cervical erosion along with detail study of cervical erosion |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/10/2025 |
| 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="10"
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
|
this is a double group , open label , comparartive clinical study on the efficacy of kushtadi yonivarti and panchvalakal kwath yoni prakshalan in the management of karnini yonivyapad w.s.r. to cervical erosion . The primary outcome of the study is managing cervical erosion patients symtpoms .Along with comparing effect of two drugs in karniini yonivyapad decribed in samhitas . For enrolling patient exclusion and inclusion criteria will be assesd . |