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CTRI Number  CTRI/2023/05/052166 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 30/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Goghrita Aschyotan (installation of drops of goghrita) In Management of dry eye . 
Scientific Title of Study   A Randomized Control Trial of Goghrita Aschyotan In Management of Shushkakshipaka with Special Reference to Dry Eye Syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Sadashiv bansode 
Designation  PG 1st year scholar 
Affiliation  Government Ayurvedic College Nagpur 
Address  dept of Shalakyatantra, OPD NO 33, Government Ayurvedic College Nagpur raje raghuji nagar sakkardhara square Nagpur Maharashtra 440024

Nagpur
MAHARASHTRA
440024
India 
Phone  8888924414  
Fax    
Email  amols.bansode11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Dhakate 
Designation  Associate Professor 
Affiliation  Government Ayurvedic College Nagpur 
Address  Dept of Shalakyatantra OPD NO 33, Government Ayurvedic College, raje raghuji nagar sakkardhara square Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Vijay Dhakate 
Designation  Associate Professor 
Affiliation  Government Ayurvedic College Nagpur 
Address  Dept of Shalakyatantra, OPD NO 33, Government Ayurvedic College, raje raghuji nagar sakkardhara square Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate@yahoo.in  
 
Source of Monetary or Material Support  
Government Ayurveda College and Hospital, Nagpur 
 
Primary Sponsor  
Name  Amol Bansode 
Address  Raje Raghuji nagar ayurvedic Layout sakkaradara square nagpur 440024 
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 Amol Bansode  Government Ayurved College and Hospital   Department of Shalakyatantra ,OPD NO 33 Government Ayurved College and Hospital,Raje Raghuji Nagar, Sakkaradar square, Nagpur
Nagpur
MAHARASHTRA 		 8888924414

amols.bansode11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurved College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushrut Uttartantra 18/45, Procedure details: • Patient should take position in which he should lie down on his back. The doctor has to open the eyes of the patient with his left hand. And has to put the drops from the bottle with his right hand from 2 Anguli (inch) height. The Goghuta eye drops packed in sterilized bottle, 4 drops were put into eyes from 2 Anguli (Inch) height. The medicine should kept in the eyes, afterwards eyes should be cleaned with Lukewarm water (Mrudu sweda), and adviced not to see the bright things. • In this )
(1) Medicine Name: goghrit , Reference: sushrut sutrasthan 45/97, Route: Ocular, Dosage Form: Ghrita, Dose: 2(NA), Frequency: qid, Duration: 28 Days
2Comparator Arm (Non Ayurveda)-Carboxy propyl methyl cellouseHydroxy propyl methyl cellulose Eye Drop will be used. Instillation of Eye drop: 2 drops 4 times a day for first 7 days. 2 drops 3 times a day for next 7 days.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient suffering from Dry Eye Syndrome.
2. Patients of age >18 years to 60 years will be selected irrespective of their
gender, caste, religion, socio-economic or educational status.
3. Patients with Myopia and Hypermetropia were selected.
4. Patients with anatomically normal ocular structures were selected.
5. Patients who are ready to accept the treatment will be selected.
 
 
ExclusionCriteria 
Details  1. Patients suffered from other systemic or infectious diseases Will be excluded
2. Patients suffered from other extra ocular diseases like ptosis, eyelid tumor that blocks the pupil not consider for study.
3. Patients suffered from intra ocular diseases like Uveitis, Glaucoma, Cataract, Retinitis Pigmentosa, Retinal Detachment, Vitreous Haemorrhage, Diabetic Retinopathy, Hypertensive Retinopathy, Optic Atrophy, Macular Hole, Maculopathy will be excluded.
4. Other traumatic and inflammatory conditions of eye will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To study the efficacy of Goghrita Aschyotan In Management of Shushkakshipaka with Special Reference to Dry Eye Syndrome duration of 28 days.
2. To study the efficacy of Hydroxy propyl methyl cellulose during 28 days of study.


 		 18 months ( follow up- baseline,7th 14th 28th day)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the Shushkakshipaka according to Ayurveda and Dry Eye Syndrome in modern point of view at duration of 28 days
 		 18 months ( follow up- baseline,7th 14th 28th day) 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/06/2023 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amols.bansode11@gmail.com].

  6. For how long will this data be available start date provided 10-06-2023 and end date provided 10-06-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
After clearance from Institutional Ethics Committee of Government Ayurved college, Nagpur, Patient visited to OPD, IPD; Casualty with complaints of rukshta, sankochit in netra and vartma, avildarshana, darunpratibodhan, gharshana, toda, bheda, shula were recruited  from OPD and IPD of  Shalakyatantra Department of Government Ayurved College, Nagpur.

During the informed consent process the subjects were given enough time to read patient information sheet and consent form. (ICF)subjects were also given freedom to ask the questions and all the questions were answered. If he/she agrees for participation in the study and if found fit to include during screening then he was recruited in the study. This visit was called as screening visit. On screening visit, after written informed consent, screening of subject on the basis of clinical assessment for Shushkakshipaka (i.e. Dry Eyes ) and fulfilling the diagnostic criteria. If all inclusion criteria is YES and all exclusion NO then subjects will be included a if necessary Subjects were then undergo general and systemic examinations. Study design will be Parallel Group Randomised Control Trial.

Intervention Group-

Goghrita Aschyotana (Eye drop) will be used for group B.

 - 1 drops of Goghrita Aschyotana (Eye Drop) 4 times a day for first 7 days.

 - 1 drops of Goghrita Aschyotana (Eye Drop) 3 times a day for next 7 days.

   Observation up to 1 Month.

   Follow up on 7th, 14th, 28thday.

Comparator Group-

A)             Hydroxy propyl methyl cellulose Eye Drop will be used for

group A.

 - 2 drops of Hydroxy propyl methyl cellulose Eye Drop 4 times a day for first 7  

    days.

 - 2 drops of Hydroxy propyl methyl cellulose Eye Drop 3 times a day for next 7

   days.


Duration of Trial drug- 28 days


 
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