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CTRI Number  CTRI/2026/04/107715 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFICACY OF VACHA,HARIDRA,SUNTHI BIDALAKA IN KLINNA VARTMA WITH REFERENCE TO SQUAMOUS CELL BLEPHARITIS. 
Scientific Title of Study   Randomised controlled trial to evaluate the efficacy of Vacha,Haridra,Sunthi Bidalaka in Klinna Vartma with reference to Squamous cell Blepharitis 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Sneha Sudhir Deshmukh 
Designation  BAMS MS Scholar 
Affiliation  PMT Ayurved College and Shri Eknath Rugnalaya ,Shevgoan 
Address  OPD NO 108 Shalakya department, shri Eknath Ayurved Rugnalaya ,PMTs Ayurved College,shevgoan,Akhegoan Road,TAL Shevgoan,Ahamdnagar

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9764496964  
Fax    
Email  snehadeashmukh150@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  vd Swati Sarwade 
Designation  HOD 
Affiliation  PMTs Ayurved college and Shri Eknath Rugnalay, Shevgoan 
Address  OPD NO 108,Shalakya department,Shri Eknath Ayurved Rugnalaya,PMTs Ayurved college,shevgoan,Akegoan Road,TAL Shevgoan,DIST Ahilyanagar

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9422935125  
Fax    
Email  drsarwadeswativ@gmail.com  
 
Details of Contact Person
Public Query  
Name  vd Sneha Sudhir Deshmukh  
Designation  BAMS MS Scholar 
Affiliation  PMTa Ayurved college,Shri Eknath Rugnalaya,Shevgoan 
Address  OPD NO 108 Shalakya Departmaent,Shri Eknath Ayurved Rugnalaya,PMTs Ayurved college,shevgoan,Akhegoan road,TAL Shevgoan,DIST Ahilyanagar

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9764496964  
Fax    
Email  snehadeashmukh150@gmail.com  
 
Source of Monetary or Material Support  
PMTs Ayurved college and Shri Eknath Ayurved Rugnalaya,Shevgoan,Akhegoan road,TAL shevgoan,DIST.Ahilyanagar,MAHARASHTRA,INDIA-414502 
 
Primary Sponsor  
Name  Vd Sneha Deshmukh 
Address  PMTs Ayurved College,Shevgoan and Shri Eknath Ayurved Rugnalaya,Shevgoan,Akhegoan road,TAL Shevgoan,DIST Ahilyanagar,MAHARASHTRA,INDIA-414502 
Type of Sponsor  Private 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 
Dr Sneha Sudhir Deshmukh  PMTs Ayurved college and Shri Eknath Rugnalaya ,Shevgoan  OPD NO 108 Shalakya Departmaent,Shri Eknath Ayurved Rugnalaya,PMTs Ayurved college,Akhegoan road,TAL Shevgoan,DIST Ahilyanagar,MAHARASHTRA,INDIA-414502
Ahmadnagar
MAHARASHTRA 		 09764496964

snehadeashmukh150@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PMTs Ayurved college Shevgoan Institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: VARTMA-ROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: Sharagadhar,Sharangdhar Samhita.Uttarkhand, Adhyaya 13 verse 30.In:Tripathi B Editors,Varanasi: Chaukhamba Surbharati Prakashan; 2012. p. 280., Procedure details: ङ्गबडालकोबङ्गहलेपोनयेतत्रयेतपश्मङ्गववङ्गजमतः ।तस्यर्ात्रापररज्ञयेतयार्ुखलयेतपङ्गविानवत्॥शा.सं.उ.१३/३०[28] Bidalaka is the application of a herbal paste on the eyelids, avoiding the eyelashes. The method is similar to applying Mukhalepa. The eyes appear like a cat’s(Bidal) eyes after the procedure, that’s why it is called Bidalaka)
(1) Medicine Name: vacha,Haridra,Sunthi bidalaka, Reference: रसांजनयेतनवालयेतपः पथ्याङ्गवश्वर्लैरङ्गप।वचाहररद्राङ्गवश्वैवामतथानागरगैररकै ः ॥१६३॥ [21] िा. प्र. ङ्गच. नयेतत्रारोगाङ्गिकारर्ध्यखंड, Route: Ocular, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-ointment chloramphenicolRoute-Local Application dose-as per required Frequency-OD duration-7days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having signs and symptoms of Klinnavartma.
2.Patients in age group between 18 to 60 yrs will be selected irrespective of their sex, religion,
socio-economic status.
3.Only those patients will be selected who are willing to give written consent.
 
 
ExclusionCriteria 
Details  1.Patient having anyother known ocular pathology.
2.Any past or present history of ocular trauma.
3.Patients with k/c/o NLDBlock, Dacrocystitis, DM, HBsAg, HIV.
4.Patient having any contagious disease.
5.Patient recently under goes eye surgeries
6.One eyed patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy Vacha,Haridra,Shunthi Bidalaka in klinnaVartma With Reference To
Squamous cell Blepharitis. 		 Vacha,Haridra,Sunthi Bidalaka Once in morning for 7 days
eye Ointment Chloramphenicol OD for 7 days
follow up on 3th,5th,7th day
Total study duration will be 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To review of literature related to klinna vartma with reference to Sqamous cell Blepharitis in
ayurvedic Samhita & modern books.
2)To review of literature related to drug Vacha, Haridra, Shunthi & Kriyakalpa Bidalaka
according to Ayurvedic Samhitas.
3)To Evaluate the Efficacy of chloramphenicol eye Ointment in klinna Vartma’
4) To Compare the efficacy of Vacha, Haridra, Sunthi Bidalaka & Chloramphenicol eye
Ointment in klinna Vartma
5)To observe adverse drug reaction, If any 		 Vacha,Haridra,Sunthi Bidalaka Once in morning for 7 days
eye Ointment Chloramphenicol OD for 7 days
follow up on 3th,5th,7th day
Total study duration will be 18 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   17/04/2026 
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 Yet Recruiting 
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  

Untreated or ill managed disease leads to complication i.e. triachiasis, madarosis, corneal erosion,

marginal keratitis etc, so this should be treated as early as possible.

The modern line of treatment topical antibiotics and steroids ointment is available but due to longterm or improper use of drugs, drug resistance and steroids induced complications develops and

recurrence of disease occurs.So need to find the safe,easily available,cost effective, and definitive treatment to cure the

condition and to check the recurrence.

Vacha,Haridra,Shunthi Bidalaka consists of Vacha having Vednahara property.

Haridra having Shothahara, Vednasthapan, Kandughana, Vranashodhana and Vranaropana.

Shunthi having shoolaghna property.

Bidalaka is easy procedure and as it is locally used, it is fast acting procedures so that patient is

relieved fastly with his symptoms.

All dravyas are economical and easily available.

 
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