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CTRI Number  CTRI/2025/04/085513 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative effect of vaginal douche of Karanja twak kashaya and Nimba twak kashaya in Vaginal itching with discharge 
Scientific Title of Study   A comparative study of Karanja twak kashaya yoni prakshalana with Nimba twak kashaya yoni prakshalana in Vulvo-vaginal candidiasis 
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 Shahina P 
Designation  PG Scholar 
Affiliation  P.N.N.M Ayurveda Medical College,Cheruthuruthy 
Address  Room no 10(O.T) Department of Prasutitantra evum Streeroga P.N.N.M Ayurveda Medical College and Hospital, Cheruthuruthy P.O, Thrissur

Thrissur
KERALA
679531
India 
Phone  9495858092  
Fax    
Email  shahinaputhoor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Salini P 
Designation  Professor and Head of Department 
Affiliation  P.N.N.M Ayurveda Medical College,Cheruthuruthi 
Address  Department of Prasutitantra evum Streeroga P.N.N.M Ayurveda Medical College and Hospital, Cheruthuruthi PO, Thrissur

Thrissur
KERALA
679531
India 
Phone  7025130539  
Fax    
Email  salipkavungal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meera Nair.N. 
Designation  Assistant Professor 
Affiliation  P.N.N.M Ayurveda Medical College,Cheruthuruthi 
Address  Department of Prasutitantra evum Streeroga P.N.N.M Ayurveda Medical College and Hospital,Cheruthuruthi.PO. Thrissur

Thrissur
KERALA
679531
India 
Phone  7025130539  
Fax    
Email  meera.nambalat@gmail.com  
 
Source of Monetary or Material Support  
P.N.N.M Ayurveda Medical College and Hospital, Cheruthuruthi PO, Thrissur,Kerala,India PIN 679531 
 
Primary Sponsor  
Name  Dr Shahina P 
Address  Department of Prasutitantra evum Streeroga P.N.N.M Ayurveda Medical College and Hospital,Cheruthuruthy PO,Thrissur,Kerala,India PIN 679531 
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 Shahina P  P.N.N.M.Ayurveda Medical College and hospital  Department of Prasutitantra evum Streeroga
Thrissur
KERALA 		 9495858092

shahinaputhoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instititional Ethical Committee P.N.N.M Ayurveda Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: Nigandu Ratnakara, Procedure details: Yoni kshalana with karanja twak kashaya for 7 days)
2Intervention ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: Gada Nigraha, Procedure details: Yoni kshalana with Nimba twak kashaya for 7 days)
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married women
Age group of 21-40 years
Subject fulfilling the above diagnostic criteria
Willingness to participate in the study 
 
ExclusionCriteria 
Details  Pregnancy
Pelvic inflammatory disease
Sexually transmitted disease
Diabetes mellitus
Recent use of antibiotics
Known case of Tuberculosis
• Known case of CA cervix
• Cases of abnormal uterine bleeding
• Use combined oral contraceptive pills
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reducing sign and symptoms of Vulvo-vaginal candidiasis  Sign and symptoms-assessment on day-1 and day-8
 
 
Secondary Outcome  
Outcome  TimePoints 
Curdy white vaginal discharge with pruritis
Positive for KOH Wet mount test 		 assessment on day 1 & day 8th  
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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/ Phase 3 
Date of First Enrollment (India)   05/05/2025 
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="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   This is a comparative interventional study. In this study, an attempt is made to compare the effect of yoni prakshalana of Karanja twak kashaya with Nimba twak kashaya in reducing the sign and symptoms of Vulvo-vaginal candidiasis. Women aged between 21-40 years are included in this study. Participants are divided in to 2 groups (19 in each group). In group A, Karanja twak kashaya yoni prakshalana and in group B, Nimba twak kashaya yoni prakshalana will be done for a period of 7 days continuously excluding menstrual phase. Yoni doshaharatwa of Karanja  is explained in Nigandu Ratnakara and Nimba twak kashaya prakshalana is mentioned Gada Nigraha. 
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