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CTRI Number  CTRI/2025/03/083397 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study On The Effectiveness Of Pippalyadi Churna In Treating Yeast Infection. 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Pippalyadi Churna In The Management Of Kaphaja Yonivyapad W.S.R 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  Dr Prerna 
Designation  PG Scholar 
Affiliation  Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh 
Address  Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  7082152836  
Fax    
Email  prernasaini0001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Jayalekshmi 
Designation  Proffessor 
Affiliation  Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh 
Address  Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  8838460272  
Fax    
Email  dr.lekshmy83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Jayalekshmi 
Designation  Proffessor 
Affiliation  Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh 
Address  Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  8838460272  
Fax    
Email  dr.lekshmy83@gmail.com  
 
Source of Monetary or Material Support  
Dr Prerna 
Kunwar Shekhar Vijendra Ayurved Medical College And Research Center Gangoh Saharanpur Uttar Pradesh 247341 
 
Primary Sponsor  
Name  Dr Prerna 
Address  Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh Saharanpur Uttar Pradesh 247341  
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 Prerna  Kunwar Shekhar Vijendra Ayurved Medical Hospital And Research Center Gangoh Saharanpur-247341  Room number 2 Department Of Prasuti Tantra- Stree Roga Kunwar Shekhar Vijendra Ayurved Hospital and Research Center Gangoh Saharanpur Uttar Pradesh
Saharanpur
UTTAR PRADESH 
7082152836

prernasaini0001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh Saharanpur  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: KAPAJA-YONIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pippalyadi Churna, Reference: ch. chi. 30/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.125(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Enrolled patients with consent form.
2.Patient complaining of any two from
Yoni Srava (Vaginal Discharge)
Yoni Pichhilta(Vaginal Sliminess)
yoni Kandu (Itching)
Alpa Vedana (Mild Pain)
•Yoni Shitalta (Vaginal Coldness)
3.Microscopically positive for Pseudohyphae.
4.Women suffering from recurrent VVC
 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in the trial.
2.Unmarried women
3.Age less than18 or more than 40 years
4.Pregnant females and lactating mothers.
5.known cases of HTN, DM, Hypo and hyperthyroidism, TB.
6.Diagnosed patients of HIV, VDRL, HBsAg
7.Women with PID and cervical intraepithelial neoplastic lesions.
8.Women taking oral contraceptive pills.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of kapahaja yonivyapad  1st,10th,20th, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in quality of life
2.Prevention of recurrence 
10th,20th,30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/04/2025 
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  

Ayurvedic texts outline 20 specific gynecological disorders, each with its own unique characteristics and implications. Kaphaja Yonivyapad is one among most frequently seen conditions out of these. It presents in the form of Pichhila (sliminess), Sheeta (cold), Pandu varna (white colored) and Kandu yukta srava (discharge with itching), Alpa Vedana (mild pain) of yoni. The sign and symptoms of Kaphaja Yoni Vyapad are correlated with Candidiasis because the the description and characteristic features of the disease have coincided with the description of Candidiasis more than any other type of Yoniroga. Vulvovaginal Candidiasis is the infection of the genital region which causes irritation, burning sensation, discharge (similar to white cottage cheese) and intense itching of the vagina and the vulva — the tissues at the vaginal opening. Yoni being a direct route to Garbhashaya (uterus), if diseased can affect entire Kshetra needed for growing embryo and its development. Hence it is important to address this problem so that women can live a healthy life. Present study is undertaken with a purpose to identify the effect of Pippalyadi Churna in the management of Kaphaja Yonivyapad w.s.r. to Vulvovaginal Candidiasis. Acharya Charaka mentioned use of this drug in yonisrava under Kaphaja Yonivyapad Chikitsa in chapter 30 of chikitsa sthan.

At first, all participants will be screened to check their eligibility for the study. A total of 30 clinically diagnosed patients will be enrolled in this study after taking informed written consent. After that, the first assessment will be done before drug administration with a validated questionnaire and grading will be done according to the signs and symptoms of the patients. Then the drug therapy will be started and the total duration will be 30 days. Three follow ups will be done each after 10 days. The last assessment will be done on the 30th day and the grading will be given again to see the changes in the signs and symptoms of kaphaja yonivyapad. Signatures on informed consent and patient information sheets will be taken on hard copy, and all other relevant data for the study will be collected. After the collection of all the relevant data, the analysis of the data will be done.

 
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