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CTRI Number  CTRI/2022/12/048597 [Registered on: 29/12/2022] Trial Registered Prospectively
Last Modified On: 28/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Kareeradi Kwath in the management of Shweta pradara 
Scientific Title of Study   Evaluate the efficacy of Kareeradi Kwath versus Panchvalkal Kwath (as Yoni Prakshalan) in the management of Shwetapradar (leucorrhoea): A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Basnal 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 
Address  Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha Department of Samhita Siddhant MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  7217474616  
Fax    
Email  basnalpooja10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Borkar 
Designation  Professor 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 
Address  Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha Department of Samhita Siddhant MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8446127058  
Fax    
Email  preeti.borkar@dmimsu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Basnal 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 
Address  Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha Department of Samhita Siddhant MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  7217474616  
Fax    
Email  basnalpooja10@gmail.com  
 
Source of Monetary or Material Support  
The clinical materials required for Shweta Pradara will be screened and enrolled from OPD and IPD of Department of Stree and Prasuti Mahatma Gandhi Ayurved College ,Hospital and Research Centre Salod Hirapur Wardha and Acharya Vinoba Bhave Rural Hospital Sawangi Wardha 
 
Primary Sponsor  
Name  Dr Pooja Basanl 
Address  Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra 442001  
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 Pooja Basnal  Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha  OPD and IPD of Dept of Stree and Prasuti MGACH and RC Salod Hirapur Wardha and AVBRH
Wardha
MAHARASHTRA 		 7217474616

basnalpooja10@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:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kareeradi kwath , Reference: Charak Samhita, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -NIL
2Comparator ArmDrugClassical(1) Medicine Name: Panchvalkal, Reference: Bhaisjya Ratnavali, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -NIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Female patients from Age 18 year to 55 year in reproductive period of life will be included in this study irrespective of marital status
Married/unmarried female’s patients will be taken for this study
Female patients having signs and symptoms of Shweta Pradaraa will be included
 
 
ExclusionCriteria 
Details  Female patients having signs and symptoms of abnormal Vaginal Bleeding such as menorrhagia metrorrhagia
Female patients having pregnancy will be excluded from this study
Female patients having Hormonal misbalance diabetes HTN Those patients who are having carcinoma or other severe systemic illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate the efficacy of Kareeradi Kwatha (as Yoni Prakshalan) in Shweta Pradara (leucorrhoea)  16 days 
 
Secondary Outcome  
Outcome  TimePoints 
evaluate the efficacy of Panchvalkal Kwath (as Yoni Prakshalan) in Shweta Pradara (leucorrhoea)
 		 2 weeks 2 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 3/ Phase 4 
Date of First Enrollment (India)   01/01/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The volunteers will be informed about the study protocol. willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACH RC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They will be divided into two groups as the trial is a parallel group, randomized, open clinical, standard controlled trial. It will include a 16 days treatment period and follow up.  
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