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CTRI Number  CTRI/2023/03/050526 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A herbal remedy to cure dry eye. 
Scientific Title of Study   AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL OF SHATADHAUTA JIVANIYA GHRITA IN THE MANAGEMENT OF SHUSHKAAKSHIPAKA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHALAKA MOHAN MORE 
Designation  ASSISTANT PROFESSOR 
Affiliation  PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY 
Address  OPD NO-108, DEPARTMENT OF SHALAKYA TANTRA, PARUL AYURVED HOSPITAL, PARUL UNIVERSITY P.O LIMDA TAL-WAGHODIA VADODARA GUJARAT
OPD NO-108, DEPARTMENT OF SHALAKYA TANTRA, PARUL AYURVED HOSPITAL, PARUL UNIVERSITY P.O LIMDA TAL-WAGHODIA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India 
Phone  7057894025  
Fax    
Email  vdshalakapawar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MANJIRI KESKAR 
Designation  PROFESSOR 
Affiliation  PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY 
Address  OPD NO 108 PARUL AYURVED HOSPITAL SHALAKYA TANTRA DEPARTMENT PARUL UNIVERSITY LIMDA VADODARA GUJARAT
OPD NO 108 PARUL AYURVED HOSPITAL SHALAKYA TANTRA DEPARTMENT PARUL UNIVERSITY LIMDA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India 
Phone  9822606358  
Fax    
Email  manjirikeskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MANJIRI KESKAR 
Designation  PROFESSOR 
Affiliation  PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY 
Address  OPD NO 108 PARUL AYURVED HOSPITAL SHALAKYA TANTRA DEPARTMENT PARUL UNIVERSITY LIMDA VADODARA GUJARAT
OPD NO 108 PARUL AYURVED HOSPITAL SHALAKYA TANTRA DEPARTMENT PARUL UNIVERSITY LIMDA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India 
Phone  9822606358  
Fax    
Email  manjirikeskar@gmail.com  
 
Source of Monetary or Material Support  
OPD NO-108, DEPARTMENT OF SHALAKYA TANTRA, PARUL AYURVED HOSPITAL, PARUL INSTITUTE OF AYURVED,PARUL UNIVERSITY P.O LIMDA TAL-WAGHODIA VADODARA GUJARAT 
 
Primary Sponsor  
Name  SELF 
Address  OPD NO-108, DEPARTMENT OF SHALAKYA TANTRA, PARUL AYURVED HOSPITAL, PARUL INSTITUTE OF AYURVED,PARUL UNIVERSITY P.O LIMDA TAL-WAGHODIA VADODARA GUJARAT 
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 SHALAKA MOHAN MORE  PARUL AYURVED HOSPITAL   OPD NO-108, DEPARTMENT OF SHALAKYA TANTRA, PARUL AYURVED HOSPITAL, PARUL INSTITUTE OF AYURVED,PARUL UNIVERSITY P.O LIMDA TAL-WAGHODIA VADODARA GUJARAT
Vadodara
GUJARAT 		 7057894025

vdshalakapawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SHUSHKAAKSHIPAKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shatadhauta Jivaniya Ghrita, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 60(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-HYDROXYPROPYL METHYLCELLULOSEIt belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. Medicine Name - Hydroxypropyl methylcellulose eye ointment, DOSE - 60 mg ,Frequency - Hs , Duration - 60 days.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients presenting with the symptoms suggestive of dry eye like irritation foreign body(sandy) sensation feeling of dryness itching non-specific ocular discomfort & classical symptoms of Shushkashipaka along with altered/effected QOL.
2 Patients of either sex aged between 20-60 years and willing to participate in this study.
3 Tear film break up time less than 10 seconds.
4 Schirmer’s -1 test positive
 
 
ExclusionCriteria 
Details  1 Patients not willing to participate in this study.
2 Severe cases of dry eye syndrome with complications like perforated corneal ulcer Uveitis Glaucoma.
3 Associated with any other inflammatory & infective ocular conditions.
4 Systemic and Autoimmune diseases causing Dry Eye Syndrome.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
RELIEF FROM SYMPTOMS OF DRY EYE   3 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
RELIEF FROM SYMPTOMS OF NARROWING OF PALPEBRAL APERATURE ROUGHNESS DRYNESS BLURRED VISION STUCK EYELIDS   3 MONTHS 
 
Target Sample Size   Total Sample Size="286"
Sample Size from India="286" 
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)   15/03/2023 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In ophthalmic practice, shushkaakshipaka is a common clinical condition. Dry eye is linked to persistent eye pain and an increased risk of ocular surface disease if left untreated. Therefore, this should be treated as soon as possible to prevent additional complications.Kriyakalpa practices such as Tarpan, parishek, and others are extremely capable of managing netra roga like Shushkaakshipaka. Unfortunately, the current state of kriyakalpa procedures is not very popular with the general public due to a number of factors, including a lack of standardization, a lack of communication between institutions, a lack of communication between generations, a lack of publication, and a lack of acceptability due to the complicated methodology.

Also, factors, for example, contact focal point wear and antagonistic natural openings, for example, dry conditions, breezy circumstances or visual entrusting can intensify the side effects of dry eye

Additionally, dry eye prevalence rises with age. Dry eye syndrome affects about 45% of people over 40, according to estimates.

Patients are frequently required to make significant lifestyle adjustments, such as discontinuing the use of contact lenses, using artificial tears five to ten times per day, having plastic or collagen plugs inserted into their punctum, switching careers to reduce computer use, or using humidity swim goggles to function.

Home confinement is a result of the corona pandemic. Working from home and e-learning also means spending more time looking at screens, which is bad for eye health.

 Therefore, finding a definitive, safe, and easily accessible treatment for the condition is urgent.

 
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