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CTRI Number  CTRI/2025/05/086345 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 03/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the efficacy of Yonidhavan with Triphala Kwath and Takra in Kaphaj Yonivyapad  
Scientific Title of Study   A Randomized Controlled clinical trial to evaluate the efficacy of Yonidhavan with Triphala Kwath and Takra in the management of Kaphaj Yonivyapad with special refference to Vulvovaginal 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  Vaishali Narayan Pargaonkar  
Designation  PG scholar  
Affiliation  APMs Ayurved Mahavidyalaya Sion Mumbai 
Address  Third floor Department of Prasutitantra and Streerog APMs Ayurved Mahavidyalaya near sion railway station Sion Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9890840579  
Fax    
Email  vaishalikale1481@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaishali Narayan Pargaonkar  
Designation  PG scholar  
Affiliation  APMs Ayurved Mahavidyalaya Sion Mumbai 
Address  Third floor Department of Prasutitantra and Streerog APMs Ayurved Mahavidyalaya near sion railway station Sion Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9890840579  
Fax    
Email  vaishalikale1481@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi Gopal Lamture 
Designation  Professor 
Affiliation  APMs Ayurved Mahavidyalaya Sion 
Address  Third floor Department of Prasutitantra and Streerog APMs Ayurved Mahavidyalaya near sion railway station Sion Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9819865834  
Fax    
Email  drplamture@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Seth RV Ayurved Hospital  
Address  APMs Ayurved Mahavidyalaya near Sion railway station Sion Mumbai 400022 
Type of Sponsor  Other [Charitable Ayurvedic Hospital ] 
 
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 Vaishali Narayan Pargaonkar  Seth RV Ayurvedic Hospital   OPD No 8 Department of Prasutitantra and Streerog APMs Ayurved Mahavidyalaya near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA 		 9890840579

vaishalikale1481@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sion Ayurved College IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: Charak chikitsastan 30 / 37, Procedure details: The patient will be placed in the lithotomy position on the Yonidhavan table A sterile rubber catheter will be attached to the Yonidhavan yantra ensuring that it will be positioned 5 to 6 feet above from the ground The rubber catheter will be inserted into the vagina & the vaginal cavity Prathamavarta will be cleaned with Triphala kwath mixed with Takra The vulva will be gently dried using a gauze pad Separate catheter will be used for each patient to ensure hygiene and prevent cross contamination)
(1) Medicine Name: Triphala Kwath and Takra, Reference: Charak chikitsastan 30 / 37, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 8 Days
2Comparator Arm (Non Ayurveda)- Clotrimazole 100mg vaginal pessaryClotrimazole is a topical broad spectrum antifungal agent used for the treatment of wide variety of Dermatophyte infections and candidiasis
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Married Women with age group 18 to 45 years
Kaphaj yoniyapad diagnosed with any clinical
signs and symptoms as
Yonigat strav vaginal discharge
Strav gandh odour
Kandu vulvovaginal itching
Katishool
Voluntary willing patients with informed written
consent
Patients irrespective of
Religion
Cast
Socioeconomic status
Occupation
 
 
ExclusionCriteria 
Details  Pregnant women
Patient with known case of Malignancy
Patients with surgical intervention such as
Cervical polyp 3rd degree Uterine prolapse
Patient with uncontrolled DM
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Yonigat strav praman that is per vaginal discharge and Sthanik kandu that is Vulvovaginal itching


 		 15 days

 
 
Secondary Outcome  
Outcome  TimePoints 
Strav gandh that is odour
Katishool that is backache 		 15 days 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   15/05/2025 
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="2" 
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   Ayurveda an ancient Indian medical system emphasizes preventive and curative health care. Womens health especially reproductive well being is a key focus in Ayurveda now addressed under a separate branch Prasuti Tantra and Stree Rog. Common gynecological issues like abnormal vaginal discharge  itching and burning urination are categorized under Yonivyapad with symptoms of Kaphaj Yonivyapad closely resembling Vulvovaginal candidiasis in modern medicine. This condition results from disturbed vaginal flora and altered pH levels. Modern treatments include antifungal drugs while Ayurveda recommends both oral and local therapies like Yoni Dhavan Pichu and Yoni Dhoopan. The current research focuses on evaluating the effectiveness of Yoni Dhavan using Triphala Kwath and Takra for managing Kaphaj Yonivyapad with special reference to vulvovaginal candidiasis. 
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