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CTRI Number  CTRI/2024/07/069717 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 06/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Interventional]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Clinical Study of Kariradi Vaginal Wash and Clotrimazole in Shwetapradar 
Scientific Title of Study   A Pharmaceutico-Analytical and Clinical study to evaluate the effect of Kariradi Vaginal Wash in Shwetapradar with special reference to Leucorrhea- A Randomized Controlled Trial 
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 Apurva Chandrakant Karande 
Designation  PG Scholar 
Affiliation  Shri Ayurved Mahavidyalaya ,Nagpur  
Address  Rasashastra and Bhaishajyakalpana Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya,Hanuman Nagar,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  8779329148  
Fax    
Email  karandeapurva235@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVishal Nandurkar 
Designation  M.D.(Ayurved) 
Affiliation  Shri Ayurved Mahavidyalaya ,Nagpur  
Address  Rasashastra and Bhaishajyakalpana Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya,Hanuman Nagar,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9545326229  
Fax    
Email  vishalnandurkar60691@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVishal Nandurkar 
Designation  M.D.(Ayurved) 
Affiliation  Shri Ayurved Mahavidyalaya ,Nagpur  
Address  Rasashastra and Bhaishajyakalpana Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya,Hanuman Nagar,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9545326229  
Fax    
Email  vishalnandurkar60691@gmail.com  
 
Source of Monetary or Material Support  
Shri Ayurved Mahavidyalaya,Nagpur 
 
Primary Sponsor  
Name  DrApurva Chandrakant Karande 
Address  Rasashastra and Bhaishajyakalpana Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur 
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 
DrApurva Chandrakant Karande  Shri Ayurved Mahavidyalaya, Nagpur  Rasashastra and Bhaishajyakalpana Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur,Pin code - 440024
Nagpur
MAHARASHTRA 		 8779329148

karandeapurva235@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Shri Ayurved Mahavidyalaya ,Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N761||Subacute and chronic vaginitis. Ayurveda Condition: SOMAR,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kariradi Vaginal Wash, Reference: Ashtang Sangraha Uttarsthan,Shlok no. 39/70, Route: Vaginal, Dosage Form: , Dose: 2(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Excessive white discharge per vagina
Itching in vagina
Burning sensation in Vagina
Duration of the disease not more than 2 years 
 
ExclusionCriteria 
Details  1.Infective Vaginitis .
• Discharge due to foreign body , chemical douche or latex condom.
2.Neoplasm
3.Gonorrheal infection
4.History of syphilis
5.Pregnancy
6.Malignancy
7.Chornic Urinary tract infection
8.Prolapsed uterus
9.Prolapsed Vagina
10.Carcinoma of cervix
11.Cervical erosion
12.Cervical fibroid
13.Anemia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Prepare Kariradi vaginal wash.
2.To analyze the organoleptic, physio-chemical and phyto-chemical tests of Kariradi Vaginal wash.
3.To evaluate and compare the efficay of kariradi vaginal wash. 		 Follow up will be every 2 weeks for 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable   Not Applicable 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 3 
Date of First Enrollment (India)   15/07/2024 
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   In the present study, total 68 participants will be taken for trial dividing them in 2 equal groups. Grp-A will receive the trial drug ’Kariradi Vaginal Wash’ and Grp-B will receive the trial drug ’Clotrimazole’  once a day for external application for 28 days. Follow up will be taken every 2 weeks for 12 weeks . Result will be concluded based on assessment criteria.  
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