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CTRI Number  CTRI/2018/10/016041 [Registered on: 16/10/2018] Trial Registered Prospectively
Last Modified On: 15/10/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Saindhava Lavana Siddha Sheetala Jala and Goksheera Seka in Management of Dry Eye 
Scientific Title of Study   Effect of netra Seka with Saindhava Lavana Siddha Sheetala Jala & Goksheera in the Management of Shushkaakshipaaka Dry Eye Syndrome A Randomized Controlled Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeev Sharma 
Designation  Pg Scholar 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre  
Address  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  8572007032  
Fax    
Email  rajeevsharma00786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun B Biradar 
Designation  Reader 
Affiliation  KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre 
Address  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  8572007032  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev Sharma 
Designation  Pg Scholar 
Affiliation  KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre 
Address  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  8572007032  
Fax    
Email  rajeevsharma00786@gmail.com  
 
Source of Monetary or Material Support  
OPD NO 27 KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka 
 
Primary Sponsor  
Name  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre 
Address  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka  
Type of Sponsor  Research institution and hospital 
 
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 Rajeev Sharma  KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya College and Hospital  KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
Belgaum
KARNATAKA 
8572007032

rajeevsharma00786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutnal Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dry Eye Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Goksheera   Goksheera seka one time a day route of administration- external application 
Intervention  Saindhava Lavana  Saindhava Lavana with sheetal jala dose 0.9 % one time a day route of admistration external application duration- 7 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients fulfilling the diagnostic criteria of Shushkaakshipaaka (Dry Eye Syndrome)
2 20 to 40 years of age group
3 Irrespective of sex occupation religion will be included
 
 
ExclusionCriteria 
Details   Age less than 20 years and more than 40 years
 Severe conditions like Steven Johnson’s syndrome, Chemical-Thermal-Radiation burns, idiopathic atrophy, Trachoma, Ocular pemphigoid
 Corneal epitheliopathies like Neuroparalytic keratitis, post-herpatic / post-measles infection of cornea,
 Conjunctival epitheliopathies like Pterygium, Pseudo-pterygium, Tumours, Retention cysts, chronic low grade bacterial / viral conjunctivitis
 Lid abnormalities like Meibominitis, Blepharitits, Facial nerve palsy, Lagophthalmous,
 Lacrimal gland diseases like infiltration of gland with sarcoidosis, lymphoma, leukemia and amyloidosis, congenital Alacrima
 Vitamin A deficiency, effect of the drugs like atropine, antihistamine, diuretics
 Specific systemic infections like Tuberculosis, Leprosy, Hypertension, RA, Diabetes mellitus, etc
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect of Saindhava Lavana Seka might be helping in reducing inflammation and hence restoration function of goblet cells and mucin secreting cells of conjunctiva might restore functioning normally
Thus might restore moisture and health of ocular surface 
1 Week 
 
Secondary Outcome  
Outcome  TimePoints 
Due to expected normalcy the tear film components and tear fluid quantity and pattern of flow may restore  1 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1 
Date of First Enrollment (India)   01/11/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Yet to start clinical trial 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Yet to start clinical trial

Watering in the eye itself is one of the clinical features of Dry Eye Syndrome, which is actually a reflex watering, induced due to dryness. This phenomenon keeps the patient away from the doctor and 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 (i.e. increased osmolarity of tears with inflammatory ocular surface disorder).

Tear deficiency, evaporative troubles, altered food – behavioural regimen, profession and modified life style 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.

In present era no one is having enough time and patience to go for lengthy procedures like Nasya, Anjana, Aschyotana, Tarpana, etc for the non-acute conditions like Dry Eye Syndrome.

Hence, there is great need of safe, effective, short-term, easily available and that can be done easily. Ghritamanda Aschyotana is one of such procedure which mimics as modern management and easily acceptable procedure.

Saindhava Lavana is having Kapha Lekhana, Shodhana, Kledahara, Chaakshushya and Shothahara property. It is being used as an ingredient of many ocular pharmaceutical preparations.

Considering all above, this study is planned to find the comparative efficacy of Saindhava Lavana Siddha Sheetala Jala & Goksheera in the management of Shushkaakshipaaka with special reference to Dry Eye Syndrome.

 
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