FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097210 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study on the effect of applying Jeevaneeya gana ghritha in the eyes of people with mild and moderate dry eye disease to see if it improves eye dryness  
Scientific Title of Study   Effect of Topical Application of Jeevaneeya gana ghritha in mild and moderate Dry eye disease - A pre and post interventional study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A G ADITHI 
Designation  P G Scholar 
Affiliation  Government Ayurveda College, Kannur 
Address  Department Of Shalakyatanthra Government Ayurveda College, Kannur Pariyaram PO 670503

Kannur
KERALA
670503
India 
Phone  7902308540  
Fax    
Email  adithiajith1106@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V K V Balakrishnan 
Designation  Professor 
Affiliation  Government Ayurveda College, Kannur 
Address  Dr V K V Balakrishnan Professor and HOD Department Of Shalakyatanthra Government Ayurveda College, Kannur Pariyaram PO

Kannur
KERALA
670503
India 
Phone  9447037892  
Fax    
Email  baluvkv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr V K V Balakrishnan 
Designation  Professor 
Affiliation  Government Ayurveda College, Kannur 
Address  Dr V K V Balakrishnan Professor and HOD Department Of Shalakyatanthra Government Ayurveda College, Kannur Pariyaram PO


KERALA
670503
India 
Phone  9447037892  
Fax    
Email  baluvkv@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr A G Adithi 
Address  Dr A G Adithi PG Scholar Department Of Shalakyatanthra Government Ayurveda College, Kannur Pariyaram PO 670503 
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 A G Adithi  Government Ayurveda College, Kannur  Department Of Shalakyatanthra
Kannur
KERALA 		 7902308540

adithiajith1106@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Ayurveda College, Kannur, Pariyaram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Ashtanga Hridayam, Procedure details: The subject will be instructed to instill 2 drops of Jeevaneeya Gana Ghritha into the eyes in supine position, & then gently wipe the area with a clean cotton ball, assisted by a bystander daily. )
(1) Medicine Name: Jeevaneeya gana ghritham, Reference: Ashtanga Hridayam , Route: Ocular, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subjects diagnosed with mild and moderate dry eye disease assessed using any one of the following
(i)OSDI Score - Greater than 13
(ii)Schirmer 1 Score - 5mm to 10mm
2.Subjects who are willing to give written informed consent 
 
ExclusionCriteria 
Details  1.Subjects suffering from other ocular diseases
2.Sjogren’s syndrome
3.Subjects who have undergone ophthalmic surgeries
4.Associated with diabetes mellitus, chronic liver diseases, endocrine diseases
5.Already undergoing topical medications for other ocular pathologies or with history of use of drugs
like steroid.
6.Subjects using contact lenses
7.Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.OSDI Score
2.Schirmer 1 Score
3.Tear Film Breakup Time 		 0th, 22nd, 29th and 36th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   20/11/2025 
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  

According to Tear Film and Ocular Surface Society Dry Eye Workshop 2 “Dry eye is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles”. Dry eye may be corelated with Sushkakshipaka, a Sarvagatha netra roga, which is Vata or Vata Pitha predominant, where Jeevaneeya gana4 is said to be effective. Jeevaneeya gana ghritha will be administered in participants diagnosed with mild and moderate dry eye disease in the age group 20 to 50 years fulfilling the inclusion criteria selected from Shalakyatathra outpatient department of Government Ayurveda College, Kannur. Assessment parameters like Ocular Surface Disease Index (OSDI) score, Schirmer I score and Tear film break up time will be noted and data collected using a case proforma. Participants will be instructed to instil 2 drops of Jeevaneeya gana ghritha at night for a period of 21 days. Post assessment will be done on 22nd, 29th and 36th day of treatment. Results will be statistically analysed with Friedman’s test, Repeated Measures of Anova and Descriptive statistics.

 
Close