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CTRI Number  CTRI/2023/08/056752 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 21/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study To Evaluate The Effect Of Triphala Kwath With Gomutra Vaginal Douching Followed By Dhatakyadi Taila Tampon In Vulvovaginal Candidiasis 
Scientific Title of Study   A Clinical Study To Evaluate The Effect Of Triphala Kwath With Gomutra Yoni Prakshalana Followed By Dhatakyadi Taila Yoni Pichu In Kaphaja Yonivyapad W.S.R. To Vulvovaginal Candidiasis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Cynthia Thakur 
Designation  M.S Scholar (Prasuti Tantra and Stree Roga 
Affiliation  Rajiv Gandhi University Of Health Sciences, Bengaluru 
Address  OPD 1, Department Of PG Studies In Prasuti Tantra And Stree Roga, Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi

Udupi
KARNATAKA
574118
India 
Phone  7380031034  
Fax    
Email  thakur.cynthia25398@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. ARPANA JAIN 
Designation  ASSISTANT PROFESSOR  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi 
Address  Department of PG Studies in Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi

Udupi
KARNATAKA
574118
India 
Phone  9880288577  
Fax    
Email  arpanajainsdm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Cynthia Thakur 
Designation  M.S Scholar (Prasuti Tantra and Stree Roga 
Affiliation  Rajiv Gandhi University Of Health Sciences, Bengaluru 
Address  OPD 1, Department Of Prasuti Tantra And Stree Roga, Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Kuthpady, Udupi

Udupi
KARNATAKA
574118
India 
Phone  7380031034  
Fax    
Email  thakur.cynthia25398@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Cynthia Thakur  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Department of PG studies in Prasuti Tantra and Stree Roga
Udupi
KARNATAKA 		 7380031034

thakur.cynthia25398@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL CLEARENCE COMMITTEE HUMAN SRI DHARAMSTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL UDUPI  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: KAPAJA-YONIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: Charak Samhita, Chikitsa Sthana, Chapter 30, Shloka 78-80, Procedure details: A sterile pichu soaked in Dhatakyadi taila will be inserted in to the vagina. The end part of Pichu should be properly left out of the vaginal orifice, with which it will be easy to remove. Yoni pichu is retained till patient gets the urge of micturition or 2-3 hours after insertion.)
2Intervention ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: Charak Samhita, Chikitsa Sthana, Chapter 30, Shloka 83-84, Procedure details: Sterilized douche nozzle will be attached to the douche can. 500ml of lukewarm Kashaya is filled in douche can which contains 400ml of freshly prepared Triphala kashaya 100ml of gomutra. About 2 inches portion of nozzle is inserted inside the vagina till the posterior fornix. A fluid is made to run from the douche can, which will be placed about 2 feet above the patient’s buttocks. The temperature of kashaya will be maintained throughout the procedure. When the kashaya gets over slowly douch)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  PATIENTS FULFILLING THE DIAGNOSTIC CRITERIA.
WOMEN AGED 18-45 YEARS
MARRIED WOMAN 
 
ExclusionCriteria 
Details  DURING MESNTRUATION
PREGNANT WOMEN
CERVICAL EROSION
MALIGNANCIES
PATIENT USING IUCDs
SEXUALLY TRANSMITTED DISEASES
K/C/O HIV, HBSAG, VDRL
SYSTEMIC DISEASES LIKE HTN, DM, TUBERCULOSIS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
REDUCTION IN YONI SRAVA WILL BE NOTED BY SUBJECTIVE PARAMETERS LIKE YONI SRAVA PRAMANA, YONI SRAVA VRANA, YONI SRAVA CONSISTENCY  FOLLOW UP ON ON DAY 21 AND DAY 35 
 
Secondary Outcome  
Outcome  TimePoints 
SYMPTOMATIC CHANGES WITH REDUCTION IN YONI KANDU AND YONI VEDNA  FOLLOW UP ON DAY 21 AND DAY 35 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/09/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  thakur.cynthia25398@gmail.com

  6. For how long will this data be available start date provided 01-09-2023 and end date provided 01-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Vaginal discharge (yoni srava) is the most common gynae complaint in reproductive age group. Vulvovaginal Candidiasis is a common mucosal infection of lower female reproductive tract caused mainly by candida albicans. Two third of the women will have at least one episode of this in her lifetime. Kaphaj yonivyapad exhibits the lakshana such as picchila yonisrava, yoni kandu, alpa vedna, yoni sheeta, which can be correlated to vulvovaginal candidiasis and the sign and symptoms of this condition are thick curdy discharge, intense itching, dull pain. Regarding the management of kaphaj yonivyapad, ruksha and ushna dravyas prayoga has been expalained. In this condition sthanika chikitsa or local treatment plays a very crucial role. Hence, the drugs possess qualities like katu kashaya rasa, laghu ruksha guna, ushna veerya and tridoshahara property are selected for the yoni prakshalana and yoni pichu. Yoni prakshalana cleanses the vagina, helps in regaining normal ph and yoni pichu does vrana ropana as it facilitates better absorption. 
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