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CTRI Number  CTRI/2025/07/091441 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 03/02/2026
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   This study evaluates the efficacy of panchavalkala tail and durva tail for garbhashayagrivagata vrana through local application (pichu) through a comparative clinical study. 
Scientific Title of Study   A comparative clinical study of panchavalkala tail yoni pichu and durva tail yoni pichu in the management of garbhashayagrivagata vrana (cervical erosion).  
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 Mina Sanap 
Designation  PG Scholar Prasuti tantra evum streeroga 
Affiliation  E.A.B.V.J.J.S.Ashwin Rural Ayurveda College,Sangamner  
Address  Ashvin Rural Ayurved College,OPD no 04, Manchi Hill, Tal- Sangamner, Dist- Ahmednagar,Maharashtra

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9096769576  
Fax    
Email  minasanap99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Vishakha Pachore 
Designation  M.S.Prasuritantra evum streeroga  
Affiliation  E.A.B.V.J.J.S.Ashwin Rural Ayurveda College,Sangamner 
Address  A.R.A.C. P.T.S.R. department OPD no 04 ,Manchi Hill Sangamner Ahmednagar Maharashtra

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9975271980  
Fax    
Email  vishakha.pachore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Vishakha Pachore 
Designation  Associate Professor, M.S. Prasuritantra evum streeroga  
Affiliation  E.A.B.V.J.J.S.Ashwin Rural Ayurveda College,Sangamner 
Address  A.R.A.C. P.T.S.R. department OPD no 04 , Manchi Hill Sangamner Ahmednagar Maharashtra

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9975271980  
Fax    
Email  vishakha.pachore@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr.Mina Sanap  
Address  Ashvin Rural Ayurved College, Manchi Hill Ashvi Bk,Sangamner, Ahmednagar Maharashtra Pin- 413 714 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Vishakha Pachore   Ashvin Rural Ayurved College, Manchi Hill Ashvi Bk,Sangamner, Ahmednagar Maharashtra Pin- 413 714 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishakha Pachore   Ashvin rural Ayurved college  A.R.A.C. P.T.S.R. department OPD no 04, Manchi Hill Sangamner Ahmednagar Maharashtra
Ahmadnagar
MAHARASHTRA 		 9975271980

vishakha.pachore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
E.A.B.V.J.J.S Ashwin Rural Ayurved College, Sangamner   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchavalkala Tail , Reference: Sharrandhar Samhita Madhyam khand, Route: Vaginal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Durva Tail, Reference: Charak Chikitsa , Route: Vaginal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Clinically diagnosed cases of Garbhashayagrivagata vrana having symptoms of Yonigata shwet strava and katishool  
 
ExclusionCriteria 
Details  1) Unmarried women and pregnant
2) Cervical polyp
3) Cervical malignancy
4) Other systemic disorder like Hypertension, diabetes , tuberculosis, HIV, HBsAg, etc .
5) Patient having coagulation disorders.

 
 
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 
Primary Outcome focuses on clinical efficiency of panchavalkala tail yoni pichu verses durva tail yoni pichu in managing garbhashayagrivagata vrana (Cervical erosion ) . It will be assess on symptomatic relief ( Yonigata shwet strava and katishool ) and objectives parameters ( site , size , apperance of erosion genral discharge , Cervical tenderness) assesment will be occure at baseline , during treatment, post treatment and follow ups.  3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Study aims to compare the effects of durva tail and panchavalkala tail in managing garbhashayagrivagata, focusing on both their local application.

1. Detailed analysis of guna and karma of panchavalkala tail and durva tail.
2) A comprehensive review of garbhashayagrivagata based on Ayurvedic samhitas.

3) A detailed study cervical erosion from modern medical perspective.

4) A comparative assessment of the efficiency of both tails in managing symptoms  		 3 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/08/2025 
Date of Study Completion (India) 25/08/2026 
Date of First Enrollment (Global)  02/08/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 - 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 [minasanap99@gmail.com].

  6. For how long will this data be available start date provided 27-07-2025 and end date provided 31-05-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   Women’s dual roles in today’s fast-paced and competitive world cause them to experience a great deal of physical and mental stress. Among these, cervical erosion (cervical ectropion) is one of the most common conditions, especially in women of reproductive age. According to Ayurveda, Acharya Vagbhata describes Karnini Yonivyapad as a condition caused by vitiated Vata affecting Shleshma and Rakta, resulting in ulcer-like growths at the cervix. In modern medicine, cervical erosion is treated with cauterization, cryosurgery, or vaporization, but these procedures can have side effects like bleeding, stenosis, and pelvic infections. Therefore, it is necessary to investigate safer and more effective Ayurvedic alternatives.
There is a need to explore effective and safer Ayurvedic alternatives. Panchvalkala Taila and Durva Taila, mentioned in classical texts, are known for their wound-healing and anti-inflammatory properties. Panchvalkala, composed of five barks—Vata, Udumbara, Plaksha, Parisha, and Ashwatha—possesses Kashaya Rasa and Sheet Virya, making it ideal for managing Garbhashaya Griva Gat Vrana. No comparative study has yet evaluated these two tailas, highlighting the need for such research.
 
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