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CTRI Number  CTRI/2024/03/064179 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study comparative effect of tila kshara pratisaran and apamarga kshara pratisaran followed by panchwalkal kwath yonidhavan in garbhashaya grivagata vrana. 
Scientific Title of Study   A Randomised parallel arm comparative clinical study to evaluate the efficacy of Tila Kshara Pratisaran and Apamarga Kshara Pratisaran followed by Panchwalkal Kwath Yonidhavan in the management of Garbhashaya Grivagata Vrana 
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 Meghna Gandhi 
Designation  PG SCHOLAR 
Affiliation  Seth Govindji Raoji ayurved Mahavidyalaya solapur  
Address  OPD no 4, Prasuti Tantra evum Streerog department,Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9270151520  
Fax    
Email  meghna.gandhi@pg.sgrayurved.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Vd Pourmima Hiremath 
Designation  Associate Professor, Prasuti Tantra evum Streerog department. 
Affiliation  Seth Govindji Raoji ayurved Mahavidyalaya solapur  
Address  OPD no 4, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9960218543  
Fax    
Email  pournima.hiremath@sgrayurved.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Meghna Gandhi  
Designation  PG SCHOLAR  
Affiliation  Seth Govindji Raoji ayurved Mahavidyalaya solapur  
Address  OPD no 4, Prasuti Tantra evum Streerog department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9270151520  
Fax    
Email  meghna.gandhi@pg.sgrayurved.edu.in  
 
Source of Monetary or Material Support  
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India 
 
Primary Sponsor  
Name  Dr Meghna Gandhi  
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meghna Gandhi   Seth Sakharam Nemchand Jain Ayurveda Rugnalaya solapur.  Prasuti Tantra evum Streerog department, OPD no 4, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002
Solapur
MAHARASHTRA 		 9270151520

meghna.gandhi@pg.sgrayurved.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya solapur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Rasa tarangini , Procedure details: 7 days (once a day in 2 nd Prahara), commencing from 8th day of menstruation for 2 consecutive cycles.)
(1) Medicine Name: Tila kshara , Reference: Rasa Tarangini , Route: Vaginal, Dosage Form: Kshara, Dose: 200(mg), Frequency: od, Duration: 14 Days
(2) Medicine Name: Panchwalkal kwath yonidhavan , Reference: Bhavprakash nighantu 14/80,81, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Rasa Tarangini , Procedure details: 7 days (once a day in 2 nd Prahara), commencing from 8th day of menstruation for 2 consecutive cycles.)
(1) Medicine Name: Apamarga Kshara , Reference: Rasa Tarangini 14/65,66, Route: Vaginal, Dosage Form: Kshara, Dose: 200(mg), Frequency: od, Duration: 14 Days
(2) Medicine Name: Panchwalkal kwath, Reference: Bhavprakash nighantu 14/80,81, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1) Married Women of Age: 21-50 years

2) Clinically diagnosed cases of Garbhashaya Grivagata Vrana having symptoms of- Yonigata strava, katishool, Yoni paka, Adhoudarshool. 
 
ExclusionCriteria 
Details  1) Pregnant or post-natal care (PNC) women

2) Cervical polyp.

3) Cervical malignancy.

4) Participant taking oral contraceptive pills and with Intra Uterine Contraceptive Devices (IUCD).

5) Other systemic disorder like, Diabetes Mellitus, AIDS, Veneral Diseases etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Tila Kshara Partisaran and Apamarga Kshara Partisaran followed
by Panchawalkal kwath Yonidhavan in the management of Garbhashaya Grivagata Vrana. 		 7 days (once a day in 2
nd Prahara), commencing from 8th day
of menstruation for 2 consecutive cycles. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study safety of Tila Kshara Partisaran followed by Panchawalkal Kwath Yonidhavan
in management of Garbhashaya Grivagata Vrana.
2.To study Nidhanpanchak of Garbhashaya Grivagat Vrana and etiopathology of cervical
erosion.
3.To study the Colposcopic observation of Garbhashaya Grivagata Vrana. 		 7 days (once a day in 2
nd Prahara), commencing from 8th day
of menstruation for 2 consecutive cycles. 
 
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   N/A 
Date of First Enrollment (India)   24/03/2024 
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="1"
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   Nowadays women have large number of complaints related with genital organs. Cervical erosion has been seen as one of the most common diseases. While going through the Ayurvedic literature it becomes evident that all the gynecological disorders are included in Yoniroga and Streeroga. Direct reference regarding cervical erosion cannot be traced in Ayurvedic classics. However, considering the pathology and main symptoms of cervical erosion, that is discharge and erosion it can be correlated with Garbhashaya Grivagata Vrana.Cervical erosion or ectopy is the commonest lesion of the cervix. The prevalence of cervical erosion ranges between 17-50%. Prevalence increases with parity but decreases with age 35 and above and it is uncommon in post-menopausal women. Hence this topic is selected to compare the efficacy of Tila Kshara Pratisaran and Apamarga Kshara Pratisaran followed by Panchwalkal Kwath Yonidhavan. The study will be conducted for 2 conservative menstrual cycle. There will be follow up on 15th day of 2nd menstrual cycle. Treatment will be on 7th day of menstruation for 7 days on pragbhakta. Before and after treatment assessment will be done with the help of colonoscopy examination. 
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