| CTRI Number |
CTRI/2025/01/079311 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Yonidhawana ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Arjuna Twaka Kashaya in p/v white discharge. |
|
Scientific Title of Study
|
Comparative Clinical Study of Arjuna Twaka Kashaya Yonidhawana and
Kankshi Siddha Jal Yonidhawana in Shwetpradara w.r.s. to Cervical
Erosion. |
| Trial Acronym |
Yes |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Shahajirao Nagtilak |
| Designation |
PG Scholar |
| Affiliation |
Shree Saptashrungi ayurved Mahavidyalaya |
| Address |
Department of Prasuti tantra and striroga OPD 3,Shree Saptashrungi ayurved Mahavidyalaya and hospital Kamal Nagar,Hirawadi Nashik Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623855109 |
| Fax |
|
| Email |
poonamsnagtilak121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Shahajirao Nagtilak |
| Designation |
PG scholar |
| Affiliation |
Shree Saptashrungi ayurved Mahavidyalaya,Nashik |
| Address |
Department of Prasuti tantra and striroga OPD 3,,Shree Saptshrungi Ayurvedic Mahavidyalaya and hospital Kamal nagar Hirawadi Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623855109 |
| Fax |
|
| Email |
poonamsnagtilak121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSunil Sadashiv More |
| Designation |
HOD,Prasuti tantra and striroga |
| Affiliation |
Shree Saptashrungi ayurved Mahavidyalaya and Hospital Nashik |
| Address |
Department of Prasuti tantra and striroga,Shree Saptshrungi Ayurvedic Mahavidyalaya and hospital Kamal nagar Hirawadi Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423934505 |
| Fax |
|
| Email |
moresunil263@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi ayurved Mahavidyalaya and hospital Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi ayurved Mahavidyalaya and hospital Nashik |
| Address |
Department of Prasuti tantra and striroga OPD 3,Shree Saptashrungi ayurved Mahavidyalaya and hospital Kamal nagar Hirawadi Nashik Maharashtra 422003 |
| Type of Sponsor |
Private 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 |
| DrPoonam Shahajirao Nagtilak |
Shree Saptashrungi ayurved Mahavidyalaya and hospital Nashik |
Department of Prasuti tantra and striroga Shree Saptashrungi ayurved Mahavidyalaya and hospital Kamal nagar Hirawadi Nashik
Nashik
MAHARASHTRA |
9623855109
poonamsnagtilak121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shree Saptashrungi ayurved Mahavidyalaya and hospital Nashik Maharashtra 422003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Yonidhawana | (Procedure Reference: Ashtanga Sangraha , Procedure details: Yoni means vagina and Dhavana or Prakshalana means cleansing of vagina. (5) It includes the douching of the vaginal canal. It is one among sixty types of Vrana Chikitsa. )
(1) Medicine Name: Kankshi Siddha Jal, Reference: Rasatarangini, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | Prakshalan karma | (Procedure Reference: Ashtanga Sangraha , Procedure details: Yoni means vagina & Dhavana or Prakshalana means cleansing of vagina. (5) It includes the douching of the vaginal canal. It is one among sixty types of Vrana Chikitsa)
(1) Medicine Name: Arjuna Twaka , Reference: Rajnighantu , Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married women |
|
| ExclusionCriteria |
| Details |
-Unmarried Women
-pregnant women
-Patients having Cervical polyp
-Patients having Cervical malignancy
-Patient who are serological positive ie HIV,VDRL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Reduce symptoms -Vaginal discharge itching at vaginal region
-Low back pain
Signs cervical ectropion cervical erosion |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO Reduce the recurrence of Shweta pradnya |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
02/02/2025 |
| 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 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
|
Primary Objective To Compare the efficacy of Arjuna Twaka Kashaya Yonidhawana in Shwetapradara. To Compare the efficacy of Kankshi Siddha Jal Yonidhawana in Shwetapradara. Secondary Objective To carry out the study of Shwetpradara w.s.r.to Cervical Erosion in detail by Ayurvedic and modern perspective. To observe and compare the obtained data. To study the concept of Yonidhawana in view of Ayurved literature and to raise the awareness of Yonidhawana process. Patients will be divided into two groups. GROUP A GROUP B Clinical assessment on 0th, 3rd,5th,7th Day Duration of drug administration 7 Days Follow up: After bleeding phase of 0,3rd,5th, and 7th day inclusion Criteria : AGE - 20-40 years, Married Women Vaginal discharge Itchinglow backachecervical ectropion Exclusion Criteria: Unmarried women Pregnant women Patients having Cervical polyp Patients having Cervical malignancy Patient who are serological positive i.e., HIV, VDRL. Withdrawal Criteria: The patient who wishes to discontinue and not ready for further participation in study will be discontinued. During the study, if any complication occurs, these patients will be excluded from the study, and she will be given management accordingly. The patient who did not continued follow up for two consecutive visits will be treated as discontinued. Primary outcome -reduce signs and symptoms of Shwetapradar. Secondary outcomes -no reccurance of Shwetapradar All data will be collecting from clinical case studies will be presented in the form of graphs, charts, healing grade etc. Patients will be observed before and after treatment. All observed data collected after the final assessment will be subjected to statistical analysis
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