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CTRI Number  CTRI/2025/09/095270 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study in women suffering from vaginal yeast infection to see whether applying an Ayurvedic oil (Udumbaradi oil) locally is as helpful as a common antifungal medicine (Clotrimazole).  
Scientific Title of Study   A randomized comparative clinical study to evaluate the effect of Udumbaradi taila pichu vs Clotrimazole vaginal tablet in the management of Shlaishmiki yonivyapad w.s.r. 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  Dr Kavitaben Rameshbhai Parmar 
Designation  Preliminary MS Ayu Scholar, Department of Prasuti Tantra Evum Stri Roga  
Affiliation  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. 
Address  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  7338073537  
Fax    
Email  kavitasihag241219@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nandan Shrivastava 
Designation  MS (Ayu) Professor, Department of Prasuti Tantra Evum Stri Roga  
Affiliation  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. 
Address  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  9984604666  
Fax    
Email  srinandan23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavitaben Rameshbhai Parmar 
Designation  Preliminary MS Ayu Scholar, Department of Prasuti Tantra Evum Stri Roga  
Affiliation  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. 
Address  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  7338073537  
Fax    
Email  kavitasihag241219@gmail.com  
 
Source of Monetary or Material Support  
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601. 
 
Primary Sponsor  
Name  Major S.D. Singh PG Ayurvedic Medical college and Hospital.  
Address  Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601. 
Type of Sponsor  Other [Private Ayush Medical college ] 
 
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 
DrKavitaben Rameshbhai Parmar  Major S.D. Singh PG Ayurvedic Medical college and Hospital   Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.
Farrukhabad
UTTAR PRADESH 
07338073537

kavitasihag241219@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Major S.D. Singh PG Ayurvedic 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:N760||Acute vaginitis. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Udumbaradi Taila Yonipichu, Reference: Charak samhita, by Dr. Harishchandra singh Kushavaha, vol 2, Published by Chaukhambha orientalia, Varanasi, Chikitsa sthana chapter no 30, yonivyapad chikitsa adhyaya, shloka no 73 to 77, page no 811., Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Clotrimazole vaginal tablet insertion Clotrimazole 100 mg vaginal tablets of standard pharma will be taken and will be gently inserted in vagina and kept overnight.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Married/Widow women aged between 18 to 45 years irrespective of caste, socio- economic
status, fulfilling the diagnostic criteria of Shlaishmiki yonivyapad.
2. Those who are willing to participate and sign a written informe consent will be included in
study.
 
 
ExclusionCriteria 
Details  1. Pregnant women.
2. Hb less than 10gm percentage.
3. Patient with genital skin lesions.
4. Patient having Diabetes Mellitus.
5. Patient on contraceptive measures and barrier methods.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Picchila Yonigata srava, yonikandu,and alpavedana will be decreased.  7 Days  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/10/2025 
Date of Study Completion (India) 10/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 our country, factors such as poor nutrition, multiple childbirths, low socio economic status, poverty, population growth, and neglect of proper hygiene contribute to many women experiencing conditions such as anemia, malnutrition, and poor health. Consequently, they are more susceptible to various gynecological disorders, including Shlaishmiki yonivyapad.
 
Shlaishmiki yonivyapad is a prevalent and pressing issue affecting women worldwide. Its symptoms, including vaginal white discharge, itching and mild vaginal pain, are often distressing. Through a comprehensive analysis of the chief complaints and a review of the disease, Shlaishmiki yonivyapad is compared to vulvovaginal candidiasis. While numerous treatments exist in modern science, they are not devoid of side effects and the risk of recurrence. Therefore, the selection of an appropriate treatment is paramount.

Classical texts outline a range of local treatments, including yoni varti or vaginal pessary, yoni dhavan or vaginal douching, yoni pichu or vaginal medicated oil tampon and yoni dhoopan or vaginal fumigation, alongside oral medications, yielding positive outcomes in managing various Yonivyapad. Given its widespread utilization and high effectiveness, sthanik chikitsa in the form of yoni pichu, especially Udumbaradi taila pichu, emerges as the preferred remedy for Shlaishmiki yonivyapad, thus justifying its selection for this study.
 
Unlike other forms of candidiasis, vulvovaginal candidiasis primarily affects immunocompetent and otherwise healthy women, particularly during their child bearing years. Although non lethal, its widespread global incidence and significant negative impact on quality-of-life underscore the urgency for a deeper understanding of the disease and the development of enhanced treatment protocols. One of the most commonly utilized medicines for the treatment of Vulvovaginal candidiasis is Clotrimazole vaginal tablet, hence it has been selected for the comparative study as the standard drug.

 
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