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CTRI Number  CTRI/2023/01/049194 [Registered on: 24/01/2023] Trial Registered Prospectively
Last Modified On: 09/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to assess the effectiveness of Khadir Vati in management of vaginal white discharge. 
Scientific Title of Study   A randomised standard controlled clinical trial to assess the efficacy of Khadir vati in the management of Shwetpradar 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Sharadrao Mahajan 
Designation  PG Scholar 
Affiliation  PDEA College Of Ayurveda and Research Centre 
Address  Department of Streeroga and Prasuti Tantra PDEA College Of Ayurveda and Research Centre Sector No 25 Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  7276564561  
Fax    
Email  nikitamahajan4561@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVinayak Shinde 
Designation  Professor Prasutitantra Department  
Affiliation  PDEA College Of Ayurveda and Research Centre 
Address  Department of Streeroga and Prasutitantra PDEA College Of Ayurveda and Research Centre Sector No 25 Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  9850933512  
Fax    
Email  drvkshinde@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Nikita Sharadrao Mahajan 
Designation  PG Scholar 
Affiliation  PDEA College Of Ayurveda and Research Centre 
Address  Department of Streeroga and Prasutitantra PDEA College Of Ayurveda and Research Centre Sector No 25 Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  7276564561  
Fax    
Email  nikitamahajan4561@gmail.com  
 
Source of Monetary or Material Support  
PDEA College Of Ayurveda and Research Centre  
 
Primary Sponsor  
Name  PDEA College Of Ayurveda and Research Centre  
Address  PDEAS College Of Ayurveda and Research Centre Sector No 25 Nigdi Pune 
Type of Sponsor  Private medical college 
 
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 
Nikita Sharadrao Mahajan  Ayurved Rugnalay and Sterling Multispeciality Hospital Sector No 27 Nigdi Pune  OPD No 119 Streerog and Prasutitantra
Pune
MAHARASHTRA 		 7276564561

nikitamahajan4561@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nagkeshar vati, Reference: Yogratnakar Uttarardha Somrogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: Patients adviced to consume Nagkeshar vati 1000mg twise a day for 14 days and patient assessment will be done on 7th and 14th day.
2Intervention ArmDrugClassical(1) Medicine Name: Khadir Vati, Reference: Dhanvantari Nighantu Guduchyadi Varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: Patients adviced to consume Khadir vati 1000mg twise a day for 14 days and patient assessment will be done on 7th and 14th day.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  The patients having clinical signs and symptoms of Shwetpradara
Yoni Kandu(Itching Vulva)
Yoni Daha(Burning)
Yoni Srava(Shwetpradar)
Lower Abdominal Pain
Low Backache 
 
ExclusionCriteria 
Details  Pregnant Women
Any type of chronic systemic disorders-TB Cancer
Patients consuming Oral Contraceptive Pills 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Khadir Vati and Nagkeshar vati follow up wise result before and after treatment in the management of Shwetpradar with help of Case Record Proforma and Clinical examination   14 days treatment with two follow ups on 7th and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
To study the side effect of drugs if any  14 days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   24/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is randomised clinical study parallel group comparing efficacy of Khadir Vati 500 mg 2 tablets twice a day and Nagkeshar Vati 500 mg 2 tablets twice a day in the management of shwetpradar for 14 days in 64 patients. 
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