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CTRI Number  CTRI/2025/09/094753 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
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   A Comparative Study on treatment of Shushkakshipaka with Special Reference To Dry Eye Disease 
Scientific Title of Study   A Comparative Clinical Study Of Keshamasi Eye Ointment And CMC Eye Ointment On Shushkakshipaka w.s.r To Dry Eye Disease 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRSAMRADNI JAGDISH GALINDE  
Designation  Post Graduate Scholar  
Affiliation  Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai 400706 
Address  Opd No.4 1st Floor Department Of Shalakyatantra Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai Maharashtra India 400706 Thane Maharashtra 400706 India

Thane
MAHARASHTRA
400706
India 
Phone  9834669726  
Fax    
Email  samradynigalinde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ASHWINI PATIL  
Designation  HOD And Professor Department Of Shalakyatantra DY Patil School Of Ayurveda Deemed To Be University  
Affiliation  Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai 400706 
Address  Opd No.4 1st Floor Department Of Shalakyatantra Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai Maharashtra India 400706 Thane Maharashtra 400706 India

Thane
MAHARASHTRA
400706
India 
Phone  8108138018  
Fax    
Email  ashwini.patil@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  DR ASHWINI PATIL 
Designation  HOD And Professor Department Of Shalakyatantra DY Patil School Of Ayurveda Deemed To Be University  
Affiliation  Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai 400706 
Address  Opd No.4 1st Floor Department Of Shalakyatantra Dr DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai Maharashtra India 400706 Thane Maharashtra 400706 India

Thane
MAHARASHTRA
400706
India 
Phone  8108138018  
Fax    
Email  ashwini.patil@dypatil.edu  
 
Source of Monetary or Material Support  
DR DY Patil School Of Ayurveda And Hospital, Deemed To Be University ,Sector 7,Nerul,Navi Mumbai, Maharashtra, India 400706 
 
Primary Sponsor  
Name  Dr DY Patil School Of Ayurveda Deemed To Be University  
Address  DR DY Patil School Of Ayurveda And Hospital, Deemed To Be University ,Sector 7,Nerul,Navi Mumbai, Maharashtra, India 400706 
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 SAMRADNI GALINDE  DR. DY Patil School Of Ayurveda And Hospital Nerul,Navi Mumbai  Opd No. 4 1st floor Department Of Shalakyatantra DR DY Patil School Of Ayurveda And Hospital Deemed To Be University Sector 7 Nerul Navi Mumbai Maharashtra India 400706
Thane
MAHARASHTRA 		 9834669726

samradynigalinde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee DY Patil School Of Ayurveda Deemed To Be University Nerul Navi Mumbai   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 ArmDrugClassical(1) Medicine Name: Carboxymethyl Eye Ointment , Reference: Parsons Diseases of Eye , Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Charak Sutrasthan , Procedure details: It is a procedure of applying medicine in the form of Gutika Raskriya churna to the inner side of lower lid margin.)
(1) Medicine Name: Keshamasi Eye Ointment , Reference: Ashtanga Hrudaya , Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: hs, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient is willing and able to participate in the study.
2. Patient presenting with signs and symptoms of Dry Eye Disease ,itching etc and lakshana of Shushkakshipaka like gharsha ,vishushkatwa , kandu , daha etc
3. Patients having mild dryness(14 to 10 mm of Schirmer test)and moderate dryness(10 to 6mm of schirmer test) 
 
ExclusionCriteria 
Details  1.Age group less than 18 years and more than 50 years
2. Patient is not willing to participate in this study
3. Allergic and inflammatory conditions of eye Ex. Acute Conjunctivitis etc
4.Patients having severe dryness in eyes( less than and equal to 5mm schirmer test)
5.Severe cases of Dry Eye Disease with complications like corneal ulcer ,uveitis ,glaucoma etc
6.Dry eye associated with sjogrens syndrome
7.Patients with known case of HTN ,Thyroid ,DM, Arthritis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduced following symptoms
Gharsha (foreign body sensation)
Vishushkatwa (dryness)
Kandu(itching)
Daha (burning sensation)
kunita vartma(sticky eyelids)
Upadeha (Heaviness of eyes) 		 3 Months  
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of symptoms of Dry Eye Disease   3 Months  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/10/2025 
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 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   Acharya Sushrut who described Shalakyatantra in Sushrut Samhita Uttartantra has described 17 sarvagat rogas and vagbhat has described 16 sarvagat rogas .Shushakakshipaka is mentioned in the classical literature of Ayurveda under sarvagata netrarogas.Shushkakshipaka is characterized by kunita daruna ruksha vartma aavila darshanam sudarunapratibodhana toda bheda and daha.Dosha is vaat dushya is rakta.It is correlated with Dry Eye Disease.It is a multifactorial disease characterized by loss of homeostatsis of the tear film and accompanied by ocular symptoms in which the tear film instability hyperosmolarity and neurosensory abnormalities.It is classified into two stages aqueous tear deficient dry eye and evaporative dry eye.Now a days it is increased because of all lifestyle changes reduced quality of life and increased stress and hormonal changes.In Ayurveda there are various kriyakalpas but now a days it is not feasible for the patients.So there is a need of advance procedure like eye ointment which is affordable easy to handle and patient friendly.which acts locally for enhancing the management of DED. 
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