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CTRI Number  CTRI/2025/03/083625 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This study compares Durva Ghrita and Shatavari Ghrita for Pittaj Yonivypad (vulvovaginitis) using a randomized trial to assess their effectiveness through oral intake (Pan) and local application (Pichu). 
Scientific Title of Study   Randomized controlled clinical trial to evaluate efficacy of durva ghrita pan and pichu with shatavari ghrita pan and pichu in the management of pittaja yonivyapad with special reference to vulvovaginitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTulsi Das 
Designation  M.S. Prasuti tantra evum streeroga 
Affiliation  L.K.R.Ayurvedic Mahavidyalay PG Training and Research Center , Gadhinglaj 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya , Prasututantra and streeroga department OPD no.05 P-2, M.I.D.C. area Gadhinglaj Dist. Kolhapur Pincode - 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  8208503130  
Fax    
Email  tulsi2017das@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarita Harshal Kamate  
Designation  M.S. Prasuti tantra evum streeroga 
Affiliation  L.K.R.Ayurvedic Mahavidyalay PG Training and Research Center , Gadhinglaj 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya ,Prasutitantra and streeroga department ,OPD NO. 05 , P-2, M.I.D.C. area Gadhinglaj Dist. Kolhapur Pincode - 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9881988389  
Fax    
Email  saritakamate9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tulsi Das 
Designation  M.S. Prasuti tantra evum streeroga 
Affiliation  L.K.R.Ayurvedic Mahavidyalay PG Training and Research Center , Gadhinglaj 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya , Prasutitantra ans streeroga department , OPD no. 05, P-2, M.I.D.C. area Gadhinglaj Dist. Kolhapur Pincode - 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  8208503130  
Fax    
Email  tulsi2017das@gmail.com  
 
Source of Monetary or Material Support  
Late Kedari Redekar Ayurvedic Mahavidyalaya , Prasutitantra ans streeroga department , OPD no. 05,P-2, M.I.D.C. area Gadhinglaj Dist. Kolhapur , Maharashtra, India Pincode - 416502  
 
Primary Sponsor  
Name  Dr. Tulsi Das 
Address  L.K.R. Ayurvedic Mahavidyalay P-2, M.I.D.C. area Gadhinglaj DIst- Kolhapur Pincode 416502 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sarita Harshal Kamate   L.K.R. Ayurvedic Mahavidyalay P-2 M.I.D.C. area Gadhinglaj DIst- Kolhapur Pincode 416502 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tulsi Das  LKR Ayurvedic Hospital  L.K.R. Ayurvedic Hospital Prasutitantra evum Streeroga department OPD NO 05 P-2 M.I.D.C. area Shendrimal Gadhinglaj DIst- Kolhapur Pincode 416502
Kolhapur
MAHARASHTRA 		 8208503130

tulsi2017das@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Late Kedari Ayurvedic Mahavidyalaya and PG Research centre Gadhinglaj   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N77||Vulvovaginal ulceration and inflammation in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Durva ghrita , Reference: Astanghridyam sutrastana and charak chikitsastana, Route: Vaginal, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - Another route orally duva ghrita pan 10 ml BID
2Comparator ArmDrugClassical(1) Medicine Name: Shatavari ghrita , Reference: Vangsen, Route: Vaginal, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Another route orally Shatavari ghrita pan 10 ml BID
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  - Diagnosed cases of pittaj yonivyapad having signs and symptoms of pittaj yonivyapad like yonidaha, yonipaka, neela peeta asita yonigat strav.
- Married females
- Irrespectives of caste, religion,social economical status  
 
ExclusionCriteria 
Details  1) Pregnant females
2) During Menses
3) H/O Diabetes mellitus
4) Patients with vulvovaginitis when seen
associated with prolapsed uterus
5) HIV,HBsAg,VDRL positive
6) Patients with benign and malignant tumours of
uterus.
7) Patients who requires surgical intervention in
cases like pelvic abcess, tuboovarian mass
patients associted with genital tubercular
infections
8) Patients with sexually transmitted diseases
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome focuses on the clinical efficacy of Durva Ghrita (pan and pichu) vs. Shatavari Ghrita (pan and pichu) in managing Pittaja Yonivyapad (Vulvovaginitis). It will be assessed based on symptomatic relief (Yoni Daha, Yoni Pak, Mutradaha, Artavagandha, Stravpraman, Strav character) and objective parameters (Aartavpraman). Assessments will occur at baseline, during treatment, post-treatment, and follow-ups.  1 week  
 
Secondary Outcome  
Outcome  TimePoints 
Study aims to compare the effects of Durva Ghrita & Shatavari Ghrita in managing Pittaja Yonivyapad, focusing on both their internal (pan) & local (pichu) applications.

1. Detailed analysis of the guna & karma of Durva Ghrita & Shatavari Ghrita.


2. A comprehensive review of Pittaja Yonivyapad based on Ayurvedic Samhitas.


3. A detailed study of vulvovaginitis from a modern medical perspective.


4. A comparative assessment of the efficacy of both Ghritas in managing symptoms 		 1 week  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/04/2025 
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)   Open to Recruitment 
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
    Response -  Analytic Code

  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 - Proposals should be directed to [tulsi2017das@gmail.com].

  6. For how long will this data be available start date provided 10-04-2024 and end date provided 31-05-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - N/A
Brief Summary  
For women’s general health as well as the health of future generations, gynecological health is essential. Through addressing “Pittaja Yonivyapad” and advancing women’s reproductive health, wecan identify imbalances early on and take preventative action to keep our health at its best. Ayurveda places a strong emphasis on preventive healthcare, and with the help of this study, women can adopt lifestyle habits that enhance general health and ward off the onset of gynecological disorders.  Pitta Prakopak ahar, travelling in hot polluted atmosphere. andalso for family planning take contraceptive pills, procedures like Cu.T Insertion, recurrent and curette. With these reasons pitta dosha increases in “StreeYoni” Today in some parts of India public common toilets are used which is main reason of spread of infection. Still in some villages cloths are used instead of Sanitary pad which are equally responsible for increasing incidence of infection. Due to change in lifestyle, modern Food habits of fast-food junk food she is unable to follow Dincharya Rutucharya, Rajaswala, Rutumati and Sutikaparicharya, which are Explained by Aacharya for women health. According to Chakrapani’s opinion Pittaja yonivypad may leads to Pittaja Asrugdar which may leads to Anemia and its 
complications. So Pittaja yonivypad should be treated in early stage to prevent further progression and complications.  
The chikitsa of Pittaja yonivyapad has been described as treated by using
o Raktopittahara Chikitsa 
o Sheetoveerya Dravyas 
o Therapies like seka, abhyanga and pichudharan 
 Therefore, in the present study Durva ghrita orally and pichudharan which has the properties like pittashamana, sheetaveeryatamaka, dahahara have been selected for the study. Additionally, there are numerous medications for the treatment of vulvo-vaginitis that vary depending on the different causes of infection. Even though these drugs help patients feel less pain, they still have side effects that interfere with their daily lives. As a result, I have decided to use Durva Ghrita as my main medication.
 
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