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CTRI Number  CTRI/2025/07/090163 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
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   EFFECT OF SHATADHOUTA GHRITA TOPICAL APPLICATION IN DRY EYE 
Scientific Title of Study   Effect of SHATADHOUTA GHRITA topical application in DRY EYE with special reference to the STATUS OF TEAR FILM A randomised open label controlled clinical trail 
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 Rasika Arvind Magdum 
Designation  PG scholar 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Research center, Shahapur, Belgaum 
Address  Chakshushya OPD NO 27 Department of Shalakyatantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi

Belgaum
KARNATAKA
590003
India 
Phone  7349570554  
Fax    
Email  magdumrasika28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunkumar Bapurao Biradar 
Designation  Professor 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Research center, Shahapur, Belgaum 
Address  Chakshushya OPD NO 27 Department of Shalakyatantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arunkumar Bapurao Biradar 
Designation  Professor 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Research center, Shahapur, Belgaum 
Address  Chakshushya OPD NO 27 Department of Shalakyatantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi Karnataka India 590003 
 
Primary Sponsor  
Name  Dr Rasika Arvind Magdum 
Address  KAHERs Shri B M Kankanwadi Ayurvedic Mahavidyalaya and Research center Shahapur,Belgaum, Karnataka 590003  
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 Rasika Arvind Magdum  KAHERs Shri B M Kankanwadi Ayurveda Hospital and MRC  Chakshushya OPD NO 27 Department of Shalakyatantra KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka India 590003
Belgaum
KARNATAKA 		 7349570554

magdumrasika28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for research on human subjects KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belgavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H00-H05||Disorders of eyelid, lacrimal system and orbit. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: shatadhouta ghrita, Reference: sharangadhara samitha uttara khanda netra prasadana 13/43, Route: Topical, Dosage Form: Ghrita, Dose: 1(g), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator Arm (Non Ayurveda)-D-Panthenol ophthalmic gel 5% D-Panthenol ophthalmic gel 5% D-Panthenol opthalmic gel 5% Duration-once daily at night for 15 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients fulfilling the diagnostic criteria of DRY EYE DISEASE that is Schirmer Test and Tear break up time
18 to 40 years of age group
Irrespective of gender occupation religion will be included

 
 
ExclusionCriteria 
Details  Subjects with diagnosed case of
Severe conditions of ocular surface disorders
Severe conditions like Steven Johnsons syndrome Chemical Thermal Radiation burns
idiopathic atrophy Trachoma Ocular pemphigoid Sjogrens Syndrome
Corneal epitheliopathies like Neuroparalytc keratitis post-herpetic or post-measles infection of cornea
Conjunctival epitheliopathies like Pterygium or Pseudo-pterygium Tumors Retention cysts chronic low grade bacterial or viral conjunctivitis
Lid abnormalities like Meibomitis Blepharitis Facial nerve palsy Lagophthalmos
Lacrimal gland diseases like infiltration of gland with sarcoidosis lymphoma leukemia amyloidosis congenital Alacrimia
Vitamin A deficiency effect of the drugs like atropine antihistamine diuretics
Specific systemic infections like Tuberculosis Leprosy Hypertension RA Diabetes mellitus
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SHATADHOUTA GHRITA may show effect in changing the status of Tear Film  Day 0th before treatment
Day 15th after treatment
Day 21th follow up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   05/12/2025 
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   NEED FOR STUDY 
Dry eye is Commonest problem encountered in present day due to multiple factors are like Aqueous deficiency defective blinking  Vitamin A deficiency  It is a situation in which there is inadequate tear volume or unstable tear film due to any other reason Watering in the eye itself is one of the clinical features of Dry Eye Syndrome which is actually reflex watering  induced due to dryness This phenomenon keeps the patient away from the doctorand makes the disease chronic  In early stages  clear watering occurs whereas in due course these secretions become turbid and turns into mucoid with  filamental debris As previously mentioned  hyperosmolarity is one of the factors contributing to ocular surface inflammation. Hyperosmolarity induces inflammation in human limbal epithelial cells by increasing expression and production of proinflammatory cytokines and chemokines This process appears to be mediated through activation of the cJun  Nterminal kinases and MAPK signaling pathways Tear deficiency evaporative troubles, altered food  behavioral regimen  profession and modified lifestyle contribute a lot for this trouble In modern medicine  Dry Eye Syndrome is palliative manageable condition  Selection of the particular tear supplement is the only non invasive treatment
There is a need of safe  effective  short term easily available and that can be done at their own place is required  SHATADHOUTA GHRITA  topical application is one of such procedure which resembles as modern management and easily acceptable procedure
Considering all above this study is planned to find the effect of SHATADHOUTA GHRITA topical application in dry eye with special referrence  to the status of  tear film

 AIM   Effect of  SHATADHOUTA GHRITA  topical application in Dry Eye with special referrence to  tear  film status

 OBJECTIVES  PRIMARY  To study the effect of  SHATADHOUTA GHRITA on specific layers of tear film

                            SECONDARY To study the effect of D Panthenol ophthalmic gel 5 percentage on specific layer of tear film

RESEARCH QUESTION Is SHATADHOUTA GHRITA effective in changing the status of Tear Film in terms of its quantity and quality

HYPOTHESIS

 H0  SHATADHOUTA GHRITA  topical application is not effective in DRY EYE with special referrence to Status of Tear Film

 H1  SHATADHOUTA GHRITA   topical application is effective in DRY EYE with special referrence to status of Tear Film

EXPECTED OUT COME

SHATADHOUTA GHRITA may show effect in changing the status of Tear Film

 

 
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