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CTRI Number  CTRI/2023/03/051056 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 25/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   An Ayurvedic Management of Dry Eyes  
Scientific Title of Study   A Comparative Study to Evaluate the Efficacy of Kantakari Ksheera seka And Paya Saindhava Seka in The Management of Shushkakshipaaka 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan dudwe 
Designation  P.G Scholar 
Affiliation  Government Ayurveda Medical College Bengaluru 
Address  department of PG Studies in Shalakya tantra
Government Ayurveda Medical College, Dhanwantari Road, Majestc, Bengaluru
Bangalore
KARNATAKA
560009
India 
Phone  8817770281  
Fax    
Email  dudwemohan900@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamataj begum yadawad 
Designation  Assistant professor 
Affiliation  Government Ayurveda Medical College Bengaluru 
Address  Government Ayurveda Medical College, Dhanwantari Road,Majestc,Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9880366101  
Fax    
Email  mmyadawad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohan dudwe 
Designation  P.G Scholar 
Affiliation  Government Ayurveda Medical College Bengaluru 
Address  department of PG Studies in Shalakya tantra
Government Ayurveda Medical College, Dhanwantari Road, Majestc, Bengaluru
Bangalore
KARNATAKA
560009
India 
Phone  8817770281  
Fax    
Email  dudwemohan900@gmail.com  
 
Source of Monetary or Material Support  
Dr mohan dudwe Government Ayurveda Medical College, Dhanwantari Road,Majestc,Bengaluru  
 
Primary Sponsor  
Name  Dr Mohan dudwe 
Address  Government Ayurveda Medical College, Dhanwantari Road,Majestc,Bengaluru 
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 Mohan dudwe  Government Ayurveda Medical College, Dhanwantari Road,Majestc,Bengaluru  Shalakya tantra OPD,Room no.11, Government Ayurveda Medical College, Dhanwantari Road,Majestc,Bengaluru
Bangalore
KARNATAKA 		 8817770281

dudwemohan900@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Government Ayurveda Medical College Bengaluru  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: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-netrapariSheka, नेत्रपरिषेक (Procedure Reference: sharangdhara samhita, Procedure details: Medicine is poured on closed eyes continuously from four Angul heights for a specific time, according to Doshas once in a day)
(1) Medicine Name: Paya saindhava seka, Reference: Gada nigraha, Route: Topical, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-netrapariSheka, नेत्रपरिषेक (Procedure Reference: sharangdhara samhita, Procedure details: Medicine is poured on closed eyes continuously from four Angul heights for a specific time, according to Doshas once in a day)
(1) Medicine Name: kantakari ksheera seka, Reference: gada nigraha, Route: Topical, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  all the patients presenting with signs and symptoms of
Sushkakshipaka irrespective of gender, caste, religion,
socio-economic status and chronicity.
 
 
ExclusionCriteria 
Details  1.Injuries(Mechanical/chemical)-Abhighataja netra roga
2.Systemic disorders like Rheumatoid arthritis, SLE and Sjögren’s
Syndrome
3.Patients who are using drugs like antihistamines, decongestants,
hormonal therapy, antidepressants, dermatologic medications,
antipsychotic medications and chemotherapy medications
4.Congenital Alacrima
5.Associated with any inflammatory and infective ocular conditions
and other conditions like glaucoma. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
schirmers test
Tearfilm Break Up Time 		 51 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessed using self generated scoring
1.Gharsha
2.Toda
3.Krichronmeela nimeelana
4.Rooksha vartmakshi
5.Daruna vartmakshi
6.Vikoonana
7.Daha 		 51 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   29/03/2023 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Sushkakshipaka is one of the Vataja(Sushruta)1 /Vata-pittaja(Vagbhata) Sarvagata, Sadhya Netrarogas. Features of Shushkakshipaka includes hard and dry eye lids, found drooping; blurred vision and difficulty to open the eyes with foreign body sensation2 . The Lakshanas of Shushkakshipaka can be equated with the signs and symptoms of Dry Eye Syndrome. Dry Eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the inter palpebral ocular surface and is associated with symptoms of ocular discomfort. The climate of tropical India and globalization along with the sprout of millions of IT professionals are making Dry Eye Syndrome, a fast growing disease, as all these leads to increased tear evaporation (due to dry wind, air conditioning, decreased blink reflex etc.) along with other causes like aqueous tear deficiency, mucin deficiency, lipid deficiency, impaired lid function, irregular corneal surface etc.The prevalence of DES in India is higher than the global prevalence and ranges from 18.4% to 54.3%. To explore effective solution in Ayurveda is the need of the hour as is no complete cure for Dry eyes in contemporary medicines at present.Some of the treatment modalities which have been tried with variable results include supplementation with tear substitutes, topical cyclosporine, mucolytic, topical retinoid, preservation of existing tears etc. along with correction of lid abnormalities, which are not long lasting and thus long-term usage is recommended. The treatment modalities that are told in classics for this are Ghritapaana, Tarpana, Seka, Aschotana, Anjana etc. which are known to increase the stability of tear film and give relief from the symptoms of Shushkakshipaka.  Hence this study is taken to overcome the challenges in treating the dry eye syndrome. 
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